NDC 71335-1139

Promethazine Hydrochloride

Promethazine Hydrochloride

Promethazine Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Promethazine Hydrochloride.

Product ID71335-1139_ea490539-007b-47b1-bef9-22de02ae7c64
NDC71335-1139
Product TypeHuman Prescription Drug
Proprietary NamePromethazine Hydrochloride
Generic NamePromethazine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2005-12-14
Marketing CategoryANDA / ANDA
Application NumberANDA040596
Labeler NameBryant Ranch Prepack
Substance NamePROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesPhenothiazine [EPC], Phenothiazines [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 71335-1139-0

14 TABLET in 1 BOTTLE (71335-1139-0)
Marketing Start Date2021-12-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-1139-3 [71335113903]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-04-04

NDC 71335-1139-7 [71335113907]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-04-04

NDC 71335-1139-4 [71335113904]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-04-04

NDC 71335-1139-0 [71335113900]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-04-04

NDC 71335-1139-9 [71335113909]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-04-04

NDC 71335-1139-8 [71335113908]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-04-04

NDC 71335-1139-1 [71335113901]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-04-04

NDC 71335-1139-5 [71335113905]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-04-04

NDC 71335-1139-6 [71335113906]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-04-04

NDC 71335-1139-2 [71335113902]

Promethazine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-04-04

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:ea490539-007b-47b1-bef9-22de02ae7c64
Manufacturer
UNII

Pharmacological Class

  • Phenothiazine [EPC]
  • Phenothiazines [CS]
  • Phenothiazine [EPC]
  • Phenothiazines [CS]

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

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

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