NDC 53746-522

Promethazine Hydrochloride

Promethazine Hydrochloride

Promethazine Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Of New York Llc. The primary component is Promethazine Hydrochloride.

Product ID53746-522_b6487bd4-8ab9-41bb-b180-58518afc7349
NDC53746-522
Product TypeHuman Prescription Drug
Proprietary NamePromethazine Hydrochloride
Generic NamePromethazine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2022-06-22
Marketing CategoryANDA /
Application NumberANDA091179
Labeler NameAmneal Pharmaceuticals of New York LLC
Substance NamePROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength50 mg/1
Pharm ClassesPhenothiazine [EPC], Phenothiazines [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 53746-522-01

100 TABLET in 1 BOTTLE (53746-522-01)
Marketing Start Date2022-06-22
NDC Exclude FlagN
Sample Package?N

Drug Details

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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.