List of Excipients in Branded Drug PROMETHAZINE

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
ANI Pharmaceuticals Inc	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	promethazine hydrochloride and dextromethorphan hydrobromide	62559-758	ALCOHOL
ANI Pharmaceuticals Inc	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	promethazine hydrochloride and dextromethorphan hydrobromide	62559-758	ANHYDROUS CITRIC ACID
ANI Pharmaceuticals Inc	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	promethazine hydrochloride and dextromethorphan hydrobromide	62559-758	ASCORBIC ACID
ANI Pharmaceuticals Inc	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	promethazine hydrochloride and dextromethorphan hydrobromide	62559-758	D&C YELLOW NO. 10
ANI Pharmaceuticals Inc	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	promethazine hydrochloride and dextromethorphan hydrobromide	62559-758	EDETATE DISODIUM
ANI Pharmaceuticals Inc	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	promethazine hydrochloride and dextromethorphan hydrobromide	62559-758	FD&C YELLOW NO. 6

Generic Drugs Containing PROMETHAZINE

Company	Ingredient	NDC	Excipient
NCS HealthCare of KY Inc dba Vangard Labs	promethazine hydrochloride	0615-1539	HYDROXYPROPYL CELLULOSE
NCS HealthCare of KY Inc dba Vangard Labs	promethazine hydrochloride	0615-1539	HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
NCS HealthCare of KY Inc dba Vangard Labs	promethazine hydrochloride	0615-1539	LACTOSE MONOHYDRATE
NCS HealthCare of KY Inc dba Vangard Labs	promethazine hydrochloride	0615-1539	MAGNESIUM STEARATE
PD-Rx Pharmaceuticals Inc	promethazine hydrochloride	43063-708	ASCORBYL PALMITATE
PD-Rx Pharmaceuticals Inc	promethazine hydrochloride	43063-708	FAT, HARD

What are the Most Frequently-Used Excipients in PROMETHAZINE?

# Of NDCs	Excipient
1	ACETIC ACID
1	ASCORBYL PALMITATE
1	CALCIUM CHLORIDE
1	EDETATE DISODIUM
1	FAT, HARD
1	FD&C YELLOW NO. 6

Excipient Strategy and Commercial Opportunities for Promethazine

Last updated: February 27, 2026

What are the key excipient considerations in promethazine formulation?

Promethazine, a phenothiazine derivative, is primarily used as an antihistamine, antiemetic, and sedative. Its formulation demands specific excipient strategies to ensure stability, bioavailability, and patient safety. The core considerations include:

• Solvent Choice: Promethazine is hydrophobic; solvents like ethanol or propylene glycol are common in injectable and liquid forms.
• pH Adjustment: Maintaining a pH around 4.0-6.0 stabilizes the drug and minimizes degradation.
• Preservatives: Methylparaben and benzyl alcohol are added in liquid formulations to inhibit microbial growth.
• Co-solvents: Glycerol or polyethylene glycol enhance solubility and stability in oral and injectable forms.
• Stabilizers: Antioxidants, such as ascorbic acid, prevent oxidative degradation.

How does excipient selection impact promethazine's commercial formulations?

Oral Preparations

• Tablets and Capsules: Use of binders, fillers (lactose, microcrystalline cellulose), and disintegrants (crospovidone) influences dissolution and absorption.
• Liquid Syrup: Propylene glycol, glycerol, and sweeteners facilitate palatability and improve bioavailability.

Injectable Formulations

• Require sterile, isotonic solutions with appropriate buffers (sodium chloride) and preservatives compatible with promethazine.
• Excipients aid in maintaining pH and stability; for instance, sodium metabisulfite acts as an antioxidant but may cause allergic reactions.

Transdermal and Topical Formulations

• Use of penetration enhancers (urea, dimethyl sulfoxide) facilitates drug absorption through the skin.

What are the key commercial opportunities linked to excipient innovation for promethazine?

Differentiation Through Formulation Innovation

• Developing preservative-free, preservative-limited, or preservative-avoiding formulations enhances safety profiles.
• Creating sugar-free or low-sugar syrups caters to diabetic or health-conscious consumers.

Extended-Release and Novel Delivery Systems

• Microsphere-based or transdermal systems extend dosing intervals, increasing patient compliance.
• Liposomal or nanoparticle formulations improve targeted delivery and reduce adverse effects.

Liquid and ODT (Orally Disintegrating Tablet) Variants

• Orally disintegrating tablets or films with taste-masking agents improve patient adherence, especially in pediatric and geriatric populations.

Manufacturing and Supply Chain Opportunities

• Utilizing excipients that qualify for low-cost, scalable production efficiencies enhances margins.
• Developing stable formulations with broad excipient compatibility reduces shelf-life and distribution costs.

Regulatory and Market Trends

• Increasing regulatory scrutiny on preservative safety creates opportunities for novel excipient systems.
• The shift towards patient-centric formulations aligns with transdermal or fast-dissolving oral forms.

Summary of key excipients and their potential roles:

Excipients	Purpose	Commercial implication
Ethanol, Propylene Glycol	Solvent, stability	Enables injectable and liquid forms; cost-effective
Binders, Fillers	Tablet integrity	Supports generics and customized formulations
Preservatives (Methylparaben, Benzyl Alcohol)	Microbial inhibition	Drives innovation in preservative-free formulations
Co-solvents	Solubility enhancement	Facilitates novel delivery systems
Stabilizers (Ascorbic Acid)	Oxidation prevention	Extends shelf-life, supports global distribution
Penetration enhancers	Transdermal absorption	Opens opportunities for new administration routes

Key takeaways

• Excipient selection critically influences promethazine formulation stability, efficacy, and safety.
• Innovation in excipient use supports differentiation through patient-centric, stable, and scalable products.
• Market opportunities extend across liquid, solid, transdermal, and controlled-release formulations.
• Regulatory shifts favor preservative-free and novel delivery systems, representing growth avenues.
• Cost-effective excipient strategies align with manufacturing efficiencies and market expansion.

FAQs

1. What are the most common excipients in promethazine injectable formulations?
   They include sterile water, buffer agents like sodium phosphate, preservatives such as benzyl alcohol, and stabilizers like sodium metabisulfite.

2. Are there safety concerns with excipients used in promethazine formulations?
   Yes, preservatives like benzyl alcohol can cause allergic reactions in neonates, and sulfite stabilizers may trigger hypersensitivity.

3. What are the new excipient innovations impacting promethazine formulations?
   Use of natural preservatives, taste-masking agents for orodispersible forms, and penetration enhancers for transdermal systems.

4. How does excipient choice influence regulatory approval?
   Novel excipients must demonstrate safety and compatibility, and formulations geared toward special populations (children, elderly) face stricter scrutiny.

5. What market sectors could benefit from advanced promethazine formulations?
   Hospitals, outpatient clinics, home care, and pediatric markets benefit from stable, patient-friendly dosage forms.

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References

[1] U.S. Food and Drug Administration. (2020). Guidance for Industry: Excipients in Drug Products.
[2] European Medicines Agency. (2021). Guideline on Excipients in the Labeling and Package Leaflet of Medicinal Products.
[3] Pharmacopeia, U.S. (USP <1079>). 2021. Stability Considerations for Parenteral Drugs.