NDC 0615-1539

Promethazine

Promethazine Hydrochloride

Promethazine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Promethazine Hydrochloride.

Product ID0615-1539_909a1473-2a2f-4ee1-94aa-a4b62a7fafdc
NDC0615-1539
Product TypeHuman Prescription Drug
Proprietary NamePromethazine
Generic NamePromethazine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2005-12-14
Marketing CategoryANDA / ANDA
Application NumberANDA040596
Labeler NameNCS HealthCare of KY, Inc dba Vangard Labs
Substance NamePROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength13 mg/1
Pharm ClassesPhenothiazine [EPC],Phenothiazines [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0615-1539-39

30 TABLET in 1 BLISTER PACK (0615-1539-39)
Marketing Start Date2005-12-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-1539-31 [00615153931]

Promethazine TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-12-14
Inactivation Date2020-01-31

NDC 0615-1539-05 [00615153905]

Promethazine TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-12-14
Inactivation Date2020-01-31

NDC 0615-1539-39 [00615153939]

Promethazine TABLET
Marketing CategoryANDA
Application NumberANDA040596
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-12-14
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE12.5 mg/1

OpenFDA Data

SPL SET ID:8a45cdf8-f569-4ce1-9aa2-13923561fced
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 992438

    • Pharmacological Class

    • Phenothiazine [EPC]
    • Phenothiazines [CS]

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

    NDCBrand NameGeneric Name
    0615-1539PromethazinePromethazine Hydrochloride
    43063-708PromethazinePromethazine
    54348-117PromethazinePromethazine
    0591-2985PHENADOZPromethazine Hydrochloride
    0591-2992PHENADOZPromethazine Hydrochloride
    0641-6082PHENERGANPromethazine Hydrochloride
    0641-6083PHENERGANPromethazine Hydrochloride
    0641-6084PHENERGANPromethazine 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
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