NDC 50436-0521

Promethazine Hydrochloride

Promethazine Hydrochloride

Promethazine Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Unit Dose Services. The primary component is Promethazine Hydrochloride.

• Product ID: 50436-0521_30c55f14-553f-4f73-a69e-d59a6c034bb9
• NDC: 50436-0521
• Product Type: Human Prescription Drug
• Proprietary Name: Promethazine Hydrochloride
• Generic Name: Promethazine Hydrochloride
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2011-03-03
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091179
• Labeler Name: Unit Dose Services
• Substance Name: PROMETHAZINE HYDROCHLORIDE
• Active Ingredient Strength: 25 mg/1
• Pharm Classes: Phenothiazine [EPC],Phenothiazines [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 50436-0521-6

3 TABLET in 1 BOTTLE (50436-0521-6)

• Marketing Start Date: 2018-09-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50436-0521-1 [50436052101]

Promethazine Hydrochloride TABLET

• Marketing Category: ANDA
• Application Number: ANDA091179
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-08-04

NDC 50436-0521-4 [50436052104]

Promethazine Hydrochloride TABLET

• Marketing Category: ANDA
• Application Number: ANDA091179
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-08-04
• Marketing End Date: 2017-12-31

NDC 50436-0521-2 [50436052102]

Promethazine Hydrochloride TABLET

• Marketing Category: ANDA
• Application Number: ANDA091179
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-08-04

NDC 50436-0521-5 [50436052105]

Promethazine Hydrochloride TABLET

• Marketing Category: ANDA
• Application Number: ANDA091179
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-08-04

NDC 50436-0521-6 [50436052106]

Promethazine Hydrochloride TABLET

• Marketing Category: ANDA
• Application Number: ANDA091179
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-09-01

Drug Details

Active Ingredients

Ingredient	Strength
PROMETHAZINE HYDROCHLORIDE	25 mg/1

OpenFDA Data

• SPL SET ID: 3cf67ac8-05b1-465b-8e57-8640ab6f444e
• Manufacturer:
  • Unit Dose Services
• UNII:
  • R61ZEH7I1I
• RxNorm Concept Unique ID - RxCUI:
  • 992447

Pharmacological Class

• Phenothiazine [EPC]
• Phenothiazines [CS]

NDC Crossover Matching brand name "Promethazine Hydrochloride" or generic name "Promethazine Hydrochloride"

NDC	Brand Name	Generic Name
0121-0927	Promethazine Hydrochloride	Promethazine Hydrochloride
0404-9940	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE
0404-9941	Promethazine Hydrochloride	Promethazine Hydrochloride
0404-9942	Promethazine Hydrochloride	Promethazine Hydrochloride
0440-5195	Promethazine Hydrochloride	Promethazine Hydrochloride
0440-8195	Promethazine Hydrochloride	Promethazine Hydrochloride
0591-5307	Promethazine Hydrochloride	Promethazine Hydrochloride
0591-5319	Promethazine Hydrochloride	Promethazine Hydrochloride
0603-1584	Promethazine Hydrochloride	Promethazine Hydrochloride
0615-7668	promethazine hydrochloride	promethazine hydrochloride
0615-8154	Promethazine Hydrochloride	Promethazine Hydrochloride
0641-0928	Promethazine Hydrochloride	Promethazine Hydrochloride
0641-0929	Promethazine Hydrochloride	Promethazine Hydrochloride
0641-0948	Promethazine Hydrochloride	Promethazine Hydrochloride
0641-0949	Promethazine Hydrochloride	Promethazine Hydrochloride
0641-0955	Promethazine Hydrochloride	Promethazine Hydrochloride
0641-0956	Promethazine Hydrochloride	Promethazine Hydrochloride
0641-1495	Promethazine Hydrochloride	Promethazine Hydrochloride
0641-1496	Promethazine Hydrochloride	Promethazine Hydrochloride
68001-161	Promethazine Hydrochloride	Promethazine Hydrochloride
68001-162	Promethazine Hydrochloride	Promethazine Hydrochloride
68001-163	Promethazine Hydrochloride	Promethazine Hydrochloride
68071-1767	Promethazine Hydrochloride	Promethazine Hydrochloride
68071-3095	Promethazine Hydrochloride	Promethazine Hydrochloride
68071-3233	Promethazine Hydrochloride	Promethazine Hydrochloride
68071-3254	Promethazine Hydrochloride	Promethazine Hydrochloride
68071-3129	Promethazine Hydrochloride	Promethazine Hydrochloride
68071-4137	Promethazine Hydrochloride	Promethazine Hydrochloride
68071-4544	Promethazine Hydrochloride	Promethazine Hydrochloride
68071-4737	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE
68071-4686	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE
68071-4424	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE
68084-154	Promethazine Hydrochloride	Promethazine Hydrochloride
68071-4514	Promethazine Hydrochloride	Promethazine Hydrochloride
68084-155	Promethazine Hydrochloride	Promethazine Hydrochloride
68071-4809	Promethazine Hydrochloride	Promethazine Hydrochloride
68151-0146	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE
68151-1584	Promethazine Hydrochloride	Promethazine Hydrochloride
68258-3011	Promethazine Hydrochloride	Promethazine Hydrochloride
68382-042	Promethazine Hydrochloride	Promethazine Hydrochloride
68382-041	Promethazine Hydrochloride	Promethazine Hydrochloride
68258-3028	Promethazine Hydrochloride	Promethazine Hydrochloride
68382-040	Promethazine Hydrochloride	Promethazine Hydrochloride
68788-7028	Promethazine Hydrochloride	Promethazine Hydrochloride
68788-7287	Promethazine Hydrochloride	Promethazine Hydrochloride
68788-9270	Promethazine Hydrochloride	Promethazine Hydrochloride
70518-0141	Promethazine Hydrochloride	Promethazine Hydrochloride
70518-0165	Promethazine Hydrochloride	Promethazine Hydrochloride
70408-146	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE
70518-0250	Promethazine Hydrochloride	Promethazine Hydrochloride