FDA.reportPublic FDA data

NDC 60429-150-30 - PROMETHAZINE HYDROCHLORIDE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
60429-150
Requested NDC
60429-150-30
Package NDCs from labels
60429-150-01, 60429-150-10, 60429-150-30
Manufacturer
Golden State Medical Supply, Inc.
Effective date
2022-12-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PROMETHAZINE HYDROCHLORIDE TABLETS, USPGolden State Medical Supply, Inc.2022-12-02HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-150-01EA - Each60429-15023c1060e-3c8a-42d2-bc21-6eec23ed3cea12012-07-24
60429-150-10EA - Each60429-1504290a1a9-6923-44e0-b41c-5b0e303f7c5f12012-07-24
60429-150-12EA - Each60429-150c0b5ddc6-ccd7-4bb6-a3cb-632e50a4839c12012-07-24
60429-150-30EA - Each60429-1505391d7e2-8e81-4ba1-aaa9-449c94ca49a912012-07-24
60429-150-60EA - Each60429-1505044c86f-172a-4ac1-9a3c-2f198450cf2112012-07-24
60429-150-90EA - Each60429-1500b4935c5-1c24-4bd5-b227-ba4b991b553512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPROMETHAZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROMETHAZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROMETHAZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
METHYLCELLULOSE (100 MPA.S)INACTIVE INGREDIENT4GFU244C4JPROMETHAZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2

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 7 · 124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEAtlantic Biologicals Corp.4f99bbd5-02f7-2fed-e063-6394a90a63552026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsbf951b5b-6e38-44a9-895e-0d60c6b9d3432026-03-27Warnings, Adverse reactionsExact identifier
rxcui: 992438
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEBryant Ranch Prepack709519cb-d124-4469-b329-b67e1bba214b2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.81fd29a9-c090-49ba-8b48-bd3656ca0c922026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEKVK-Tech, Inc.7a137adf-39b7-4b14-80da-c3cac9ad562a2026-03-13Warnings, Adverse reactionsExact identifier
application number: ANDA040712
ndc (product): 10702-002
ndc (product): 10702-004
ndc (product): 10702-003
rxcui: 992475
rxcui: 992447
rxcui: 992438
spl id: 4ceccb65-dd65-461c-e063-6294a90afcda
spl set id: 7a137adf-39b7-4b14-80da-c3cac9ad562a
unii: R61ZEH7I1I
PhenerganPROMETHAZINE HCLDirect_Rxeec705f7-123a-7926-e053-2a95a90af46d2026-03-05Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEHenry Schein, Inc.7fa840ad-10e7-4faf-9325-4516486041612026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEREMEDYREPACK INC.adb04635-584f-4fef-98ca-2574be312a732026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992438
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEChartwell RX, LLC2ca17cd4-460e-4d54-8c53-a58a2b80e5cb2026-01-30Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDECardinal Health 107, LLC7ce351d8-47be-4937-aad2-153208c93b532026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine and Phenylephrine HCl, and Codeine PhosphatePROMETHAZINE, PHENYLEPHRINE, CODEINEAmneal Pharmaceuticals LLC5f23b254-872b-4e88-91be-710c3ea7687b2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLCf6ca1097-1c75-c682-e053-6294a90a2bd62026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLCd9cb1a44-d646-d9e9-e053-2995a90a24ff2026-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA040712
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLC075f052e-7f38-7f75-e063-6394a90a512b2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLCba4ec2d8-1da4-473b-9ef8-57051cb2c0f72025-12-26Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLC0b5734b8-6a52-44ff-ac29-9a91a43353942025-12-20Warnings, Adverse reactionsExact identifier
rxcui: 992475
rxcui: 992447
rxcui: 992438
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEProPharma Distribution38673af1-112e-9ddd-e063-6294a90af4652025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Codeine PhosphatePROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATECosette Pharmaceuticals, Inc.3b02cda4-9b24-79c9-e063-6294a90af5b92025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Codeine PhosphatePROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATECranbury Pharmaceuticals, LLC785c605e-1907-4fac-8b69-d504a2076f8e2025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDECranbury Pharmaceuticals, LLCa8b57027-a4b8-4149-93e8-aa3e7a6d6dc32025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I

Reported adverse events (FAERS/openFDA)#

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