Details for New Drug Application (NDA): 016964
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NDA 016964 describes MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE, which is a drug marketed by Hospira and is included in one NDA. It is available from two suppliers. Additional details are available on the MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE profile page.
The generic ingredient in MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE is bupivacaine hydrochloride; epinephrine bitartrate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride; epinephrine bitartrate profile page.
The generic ingredient in MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE is bupivacaine hydrochloride; epinephrine bitartrate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride; epinephrine bitartrate profile page.
Summary for 016964
| Tradename: | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE |
| Applicant: | Hospira |
| Ingredient: | bupivacaine hydrochloride; epinephrine bitartrate |
| Patents: | 0 |
Pharmacology for NDA: 016964
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 016964
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MARCAINE HYDROCHLORIDE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 016964 | NDA | Henry Schein, Inc. | 0404-9906 | 0404-9906-10 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9906-10) / 10 mL in 1 VIAL, SINGLE-DOSE |
| MARCAINE HYDROCHLORIDE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 016964 | NDA | Henry Schein, Inc. | 0404-9907 | 0404-9907-30 | 1 PACKAGE in 1 BAG (0404-9907-30) / 30 mL in 1 PACKAGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.25% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.25%;0.0091MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
Profile for product number 005
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.5% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
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