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Last Updated: December 12, 2019

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Diphenhydramine hydrochloride - Generic Drug Details

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What are the generic sources for diphenhydramine hydrochloride and what is the scope of freedom to operate?

Diphenhydramine hydrochloride is the generic ingredient in seventeen branded drugs marketed by Mcneil Cons, Alra, Anabolic, Elkins Sinn, Fosun Pharma, Halsey, Heather, Heritage Pharma, Hikma Intl Pharms, Impax Labs, Ivax Sub Teva Pharms, Lannett, Lederle, LNK, Mk Labs, Mutual Pharm, Newtron Pharms, Nexgen Pharma Inc, Perrigo, Pioneer Pharms, Purepac Pharm, Pvt Form, Roxane, Sun Pharm Industries, Superpharm, Teva, Valeant Pharm Intl, Vangard, Watson Labs, Whiteworth Town Plsn, Cenci, Usl Pharma, Bundy, Kv Pharm, Naska, Pharm Assoc, Alpharma Us Pharms, App Pharms, Bel Mar, Dr Reddys, Eurohlth Intl Sarl, Hospira, Lyphomed, Micro Labs, Mylan Institutional, West-ward Pharms Int, Wyeth Ayerst, Abraxis Pharm, Fresenius Kabi Usa, Intl Medication, Parke Davis, Morton Grove, Cumberland Swan, Hi Tech Pharma, Lannett Co Inc, Warner Chilcott, Pfizer, Aurobindo Pharma Ltd, Bionpharma Inc, Strides Pharma, Bayer Hlthcare, Amneal Pharms Co, Apotex Inc, P And L, and Perrigo R And D, and is included in ninety-eight NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for diphenhydramine hydrochloride. Nineteen suppliers are listed for this compound.

Drug Sales Revenue Trends for diphenhydramine hydrochloride

See drug sales revenues for diphenhydramine hydrochloride

Recent Clinical Trials for diphenhydramine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Christian Fromm, MDPhase 2
James A. KeeneyPhase 4
Indiana UniversityPhase 3

See all diphenhydramine hydrochloride clinical trials

Pharmacology for diphenhydramine hydrochloride
Medical Subject Heading (MeSH) Categories for diphenhydramine hydrochloride
Synonyms for diphenhydramine hydrochloride
.alpha.-Hydroxydiphenylmethane-.beta.-dimethylaminoethyl ether hydrochloride
.beta.-Dimethylaminoethyl benzhydryl ether hydrochloride
[2-(diphenylmethoxy)ethyl]dimethylamine hydrochloride
[2-(diphenylmethoxy)ethyl]dimethylamine, chloride
147-24-0
2-(benzhydryloxy)-N,N-dimethylethan-1-amine hydrochloride
2-(benzhydryloxy)-N,N-dimethylethanamine hydrochloride
2-(Benzhydryloxy)-N,N-dimethylethylamine hydrochloride
2-(diphenylmethoxy)-N,N-dimethylethanamine h ydrochloride
2-(diphenylmethoxy)-N,N-dimethylethanamine hydrochloride
2-(Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride
2-[(diphenylmethyl)oxy]-N,N-dimethylethanamine hydrochloride
2-benzhydryloxy-N,N-dimethyl-ethanamine hydrochloride
2-benzhydryloxy-N,N-dimethylethanamine hydrochloride
2-benzhydryloxy-N,N-dimethylethanamine;hydrochloride
2-benzhydryloxyethyl-N,N-dimethylammonium chloride
2-Diphenylmethoxy-N,N-dimethylethanamine hydrochloride
2-Diphenylmethoxy-N,N-dimethylethylamine hydrochloride
2-Diphenylmethoxy-N,N-dimethylethylamine hydrochloride; N-(2-Diphenylmethoxyethyl)-N,Ndimethylamine hydrochloride
8052-21-9
AB0011241
AB1009368
AC-3449
AC1L1S27
ACMC-209tgi
AKOS005287308
Allergan
Allergival
alpha-(2-dimethylaminoethoxy)diphenylmethane hydrochloride
alpha-hydroxydiphenylmethane-beta-dimethylaminoethyl ether hydrochlori de
alpha-Hydroxydiphenylmethane-beta-dimethylaminoethyl ether hydrochloride
Ambenyl
AN-12960
ANW-42448
ARONIS25348
AS-12088
Asdrin
Banophen
Bayer Select Night Time Pain Relief
BC205545
BCP13546
Bena
Benadril hydrochloride
Benadryl (TN)
Benadryl hydrochloride
Benadryl Preservative Free
Bendylate
Benocten
Benzantin
Benzantin hydrochloride
Benzehist
Benzhydramine HCl
Benzhydramine hydrochloride
Benzhydramine hydrochloride; 2-(Benzhydryloxy)-N,N-dimethylethylamine hydrochloride; N-(2-Diphenylmethoxyethyl)-N,N-dimethylamine hydrochloride
Benzhydrol, beta-dimethylaminoethyl ether hydrochloride
beta-Dimethylaminoethanol diphenylmethyl ether hydrochloride
beta-dimethylaminoethyl benzhydryl ether hydroch loride
beta-Dimethylaminoethyl benzhydryl ether hydrochloride
C07784
Caladryl
Carphenamine
Carphenex
CAS-147-24-0
Cathejell
CCG-39755
CCRIS 2383
CHEBI:4637
CHEMBL1620
component of Bena-Fedrin
component of Caladryl
CPD000058353
CS-2340
CTK3J2554
D 3630
D00669
D0423
Daedalon
Denydryl
difenhydramine h ydrochloride
Difenhydramine hydrochloride
Dimedrol
Dimedrol hydrochloride
Dimedrol-hydrochloride
Dimedrolum
Dimethylamine benzhydryl ester hydrochloride
Diphamine
Diphenhydramine (hydrochloride)
Diphenhydramine HCl
Diphenhydramine HCl (Benadryl)
Diphenhydramine Hcl Preservative Free
Diphenhydramine hydrochloride (JP17/USP)
Diphenhydramine hydrochloride [BAN:JAN]
Diphenhydramine hydrochloride [USP:BAN:JAN]
Diphenhydramine Hydrochloride 1.0 mg/ml in Methanol (as free base)
Diphenhydramine hydrochloride preservative free
Diphenhydramine hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material
Diphenhydramine hydrochloride, >=98% (HPLC)
Diphenhydramine hydrochloride, 99%
Diphenhydramine hydrochloride, analytical standard
Diphenhydramine hydrochloride, British Pharmacopoeia (BP) Reference Standard
Diphenhydramine hydrochloride, European Pharmacopoeia (EP) Reference Standard
Diphenhydramine hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Diphenhydramine hydrochloride, United States Pharmacopeia (USP) Reference Standard
Diphenhydramine Hydrochloride,(S)
Diphenhydramine.HCl
Diphenydramine hydrochloride
Diphenylhydramine hydrochloride
Dipjemhist
Dobacen hydrochloride
DSSTox_CID_537
DSSTox_GSID_20537
DSSTox_RID_75646
DTXSID4020537
EBD1627
EINECS 205-687-2
Eldadryl
Ethanamine, 2-(diphenylmet hoxy)-N,N,dimethyl-, hydrochloride
Ethanamine, 2-(diphenylmethoxy)-N,N-dimethyl-, hydrochloride
Ethanamine, 2-(diphenylmethoxy)-N,N-dimethyl-, hydrochloride (1:1)
Ethanamine, 2-(diphenylmethoxy)-N,N,dimethyl-, hydrochloride
Ethylamine, 2-(diphenylmethoxy)-N,N-dimethyl-, hydrochloride
Ethylamine,N-dimethyl-2-(diphenylmethoxy)-, hydrochloride
EU-0100377
Felben
Fenylhist
FT-0652576
Halbmond
Histacyl
HMS1568M11
HMS1920I06
HY-B0303A
Hydryllin
Jsp002743
KS-00000X1C
KS-0000477U
KSC492K5J
LP00377
LS-67
MCULE-3867814648
MFCD00012479
MFCD00012479 (95%)
MLS000028428
MLS000758216
MLS001148114
MLS001423951
MLS002222180
MolPort-000-837-708
N-(2-Diphenylmethoxyethyl)-N,N-dimethylamine hydrochloride
N-(2-Diphenylmethoxyethyl)-N,N-dimethylaminehydrochloride
N-[2-Diphenylmethoxyethyl]-N,N-dimethylamine
N,N-dimethyl-2-(diphenylmethoxy)ethylamine hydrochloride
NC00060
NCGC00015335-09
NCGC00024414-05
NCGC00093809-01
NCGC00093809-02
NCGC00093809-03
NCGC00093809-04
NCGC00093809-05
NCGC00254264-01
NCGC00259023-01
NCGC00261062-01
NCI-C56075
Noctomin
NSC 33299
NSC-33299
NSC-756729
NSC33299
NSC756729
O-benzhydryldimethylaminoethanol hydrochloride
Opera_ID_152
Paradryl
PCHPORCSPXIHLZ-UHFFFAOYSA-N
Pharmakon1600-01500256
Prestwick_177
Prodryl
Q-201003
REGID_for_CID_8980
Resmin
Restamin
Rohydra
RTX-012323
s1866
SAM001247024
SC-80236
SCHEMBL17071
Se dopretten
Secundal-D
Sedopretten
Sekundal-D
SK-Diphenhydramine
Sleep-Eze-3
SMR000058353
SPECTRUM1500256
SR-01000003069
SR-01000003069-10
SR-01000003069-2
ST24039533
ST45054142
SW198731-2
SY010546
TC2D6JAD40
TL8001037
Tox21_112991
Tox21_201472
Tox21_300611
Tox21_500377
Tylenol Cold Night Time Liquid
Tylenol PM Tablets/Caplets
UNII-TC2D6JAD40
Valdrene
Vena
Vicks Formula 44
Wehydryl
WLN: 1N1 & 2OYR & R & GH

US Patents and Regulatory Information for diphenhydramine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vangard DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride CAPSULE;ORAL 088034-001 Oct 27, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Perrigo ANTITUSSIVE diphenhydramine hydrochloride SYRUP;ORAL 071292-001 Apr 10, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Elkins Sinn DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride CAPSULE;ORAL 085701-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Pfizer ADVIL PM diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 021393-001 Dec 21, 2005 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Lannett DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride CAPSULE;ORAL 080868-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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