FDA.reportPublic FDA data

Application 040713

Type
ANDA
Sponsor
KVK TECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDETABLET;ORAL50MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEHenry Schein, Inc.7fa840ad-10e7-4faf-9325-4516486041612026-03-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEREMEDYREPACK INC.adb04635-584f-4fef-98ca-2574be312a732026-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEChartwell RX, LLC2ca17cd4-460e-4d54-8c53-a58a2b80e5cb2026-01-30Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDECardinal Health 107, LLC7ce351d8-47be-4937-aad2-153208c93b532026-01-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLCf6ca1097-1c75-c682-e053-6294a90a2bd62026-01-01Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLCd9cb1a44-d646-d9e9-e053-2995a90a24ff2026-01-01Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLC075f052e-7f38-7f75-e063-6394a90a512b2026-01-01Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLCba4ec2d8-1da4-473b-9ef8-57051cb2c0f72025-12-26Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLC0b5734b8-6a52-44ff-ac29-9a91a43353942025-12-20Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEProPharma Distribution38673af1-112e-9ddd-e063-6294a90af4652025-12-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
promethazine hydrochloridePROMETHAZINE HYDROCHLORIDECranbury Pharmaceuticals, LLCd32ea9db-11d4-400d-b7ef-dd0ec01b796d2025-12-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: promethazine hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEProPharma Distribution45b09a50-dab2-e83d-e063-6394a90aa8132025-12-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
promethazine hydrochloridePROMETHAZINE HYDROCHLORIDEATLANTIC BIOLOGICALS CORP69934bbb-922c-4752-b253-f2f07340de8d2025-12-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: promethazine hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutions46b869e2-9305-43ae-bb15-919a6d09b6ff2025-12-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEChartwell Governmental & Specialty RX, LLC.e5d2156d-1f66-4fdf-a3ae-5e1325218c8b2025-11-21Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAmerican Health Packaginga8fe4bc5-961b-4441-b8e2-ef93e4e137b62025-11-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAmerican Health Packaging57b4bf23-c563-4357-9dcf-066cbc1280e42025-11-13Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHenry Schein, Inc.d7675718-0a57-41ff-a771-79afc12150aa2025-11-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHenry Schein, Inc.c525cb2c-9a01-4a9b-ad2c-08630719953d2025-11-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDECardinal Health 107, LLCe16238dc-9292-49ac-b80f-8afeccb88bc52025-10-24Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60429-151PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent