NDC 0641-0929

Promethazine Hydrochloride

Promethazine Hydrochloride

Promethazine Hydrochloride is a Intramuscular Injection in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Promethazine Hydrochloride.

Product ID0641-0929_5f749fe3-2034-49fc-864a-34ecb630b2bf
NDC0641-0929
Product TypeHuman Prescription Drug
Proprietary NamePromethazine Hydrochloride
Generic NamePromethazine Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR
Marketing Start Date1973-09-19
Marketing CategoryANDA / ANDA
Application NumberANDA083312
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NamePROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength50 mg/mL
Pharm ClassesPhenothiazine [EPC], Phenothiazines [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0641-0929-25

25 VIAL, SINGLE-DOSE in 1 PACKAGE (0641-0929-25) > 1 mL in 1 VIAL, SINGLE-DOSE (0641-0929-21)
Marketing Start Date1973-09-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0641-0929-21 [00641092921]

Promethazine Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA083312
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1973-09-19

NDC 0641-0929-25 [00641092925]

Promethazine Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA083312
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1973-09-19

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE50 mg/mL

OpenFDA Data

SPL SET ID:4bf3912c-8339-401e-9711-dad6acf15f11
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 992460
  • 992858

    • 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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