NDC 64679-761

PROMETHAZINE HCL

Promethazine Hydrochloride

PROMETHAZINE HCL is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Wockhardt Usa Llc.. The primary component is Promethazine Hydrochloride.

Product ID64679-761_7555f67d-ea85-44e4-9ed4-9c84d7f76c69
NDC64679-761
Product TypeHuman Prescription Drug
Proprietary NamePROMETHAZINE HCL
Generic NamePromethazine Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2009-12-23
Marketing CategoryANDA / ANDA
Application NumberANDA040785
Labeler NameWockhardt USA LLC.
Substance NamePROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength50 mg/mL
Pharm ClassesPhenothiazine [EPC],Phenothiazines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 64679-761-01

25 VIAL, SINGLE-DOSE in 1 CARTON (64679-761-01) > 1 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2009-12-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64679-761-04 [64679076104]

PROMETHAZINE HCL INJECTION
Marketing CategoryANDA
Application NumberANDA040785
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-23

NDC 64679-761-03 [64679076103]

PROMETHAZINE HCL INJECTION
Marketing CategoryANDA
Application NumberANDA040785
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-23

NDC 64679-761-01 [64679076101]

PROMETHAZINE HCL INJECTION
Marketing CategoryANDA
Application NumberANDA040785
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-23

NDC 64679-761-02 [64679076102]

PROMETHAZINE HCL INJECTION
Marketing CategoryANDA
Application NumberANDA040785
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-23

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE50 mg/mL

OpenFDA Data

SPL SET ID:cb06c97d-3b98-4c29-bcb2-5b04f41db481
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 992460
  • 992858

    • Pharmacological Class

    • Phenothiazine [EPC]
    • Phenothiazines [CS]

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

    NDCBrand NameGeneric Name
    52533-204Promethazine HClPromethazine HCl
    52533-177Promethazine HClPromethazine HCl
    64679-760PROMETHAZINE HCLPROMETHAZINE HCL
    64679-761PROMETHAZINE HCLPROMETHAZINE HCL
    0591-2985PHENADOZPromethazine Hydrochloride
    0591-2992PHENADOZPromethazine Hydrochloride
    0641-6082PHENERGANPromethazine Hydrochloride
    0641-6083PHENERGANPromethazine Hydrochloride
    0641-6084PHENERGANPromethazine Hydrochloride
    0615-1539PromethazinePromethazine Hydrochloride
    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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.