NDC 43063-874

PROMETHAZINE HYDROCHLORIDE

Promethazine Hydrochloride

PROMETHAZINE HYDROCHLORIDE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Promethazine Hydrochloride.

Product ID43063-874_84771ac5-acf4-e0ec-e053-2a91aa0a1b36
NDC43063-874
Product TypeHuman Prescription Drug
Proprietary NamePROMETHAZINE HYDROCHLORIDE
Generic NamePromethazine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2006-07-31
Marketing CategoryANDA / ANDA
Application NumberANDA040712
Labeler NamePD-Rx Pharmaceuticals, Inc.
Substance NamePROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesPhenothiazine [EPC],Phenothiazines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43063-874-01

100 TABLET in 1 BOTTLE, PLASTIC (43063-874-01)
Marketing Start Date2018-08-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43063-874-20 [43063087420]

PROMETHAZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-07

NDC 43063-874-79 [43063087479]

PROMETHAZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-11-07

NDC 43063-874-15 [43063087415]

PROMETHAZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-08-20

NDC 43063-874-30 [43063087430]

PROMETHAZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-09-05

NDC 43063-874-12 [43063087412]

PROMETHAZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-08-20

NDC 43063-874-10 [43063087410]

PROMETHAZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-07-30

NDC 43063-874-02 [43063087402]

PROMETHAZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-11-11

NDC 43063-874-95 [43063087495]

PROMETHAZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-08-17

NDC 43063-874-01 [43063087401]

PROMETHAZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-08-16

NDC 43063-874-04 [43063087404]

PROMETHAZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-08-27

NDC 43063-874-06 [43063087406]

PROMETHAZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-08-27

NDC 43063-874-05 [43063087405]

PROMETHAZINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-09-06

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:5ce082e9-13eb-4e63-a9e2-657d3ef0e9f8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 992447
    • UPC Code
  • 0343063874011

    • Pharmacological Class

    • 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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