FDA.reportPublic FDA data

NDC 68071-3816-01 - Phentermine 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
68071-3816
Requested NDC
68071-3816-01
Package NDCs from labels
68071-3816-1, 68071-3816-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2025-03-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Phentermine Hydrochloride - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2025-03-25HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3816-1Phentermine Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3816PHENTERMINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]1Current NDC, 1 package rows20250327_312d9742-6a65-c1cb-e063-6394a90a2e66.zip

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 6 of 9 · 180 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDESUNRISE PHARMACEUTICAL, INC.a0439c85-5ede-4e02-aed2-47debd2c8eb22025-07-08Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack723c37c4-868f-40f0-b74d-137dcbb93f9f2025-06-02Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepacka1bca4b5-df64-4bac-a3a2-67f5c1eddbce2025-05-12Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.f3b43443-dcf3-4a0d-a919-1be1bb9495ed2025-04-24Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.315b8a94-b7cc-1b47-e063-6294a90a2d392025-03-27Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.312d9742-6a65-c1cb-e063-6394a90a2e662025-03-25Warnings, Adverse reactionsExact identifier
application number: ANDA040526
ndc (package): 68071-3816-1
ndc (product): 68071-3816
ndc11 (package): 68071381601
spl id: 312da1f3-1909-cc1d-e063-6394a90adc5e
spl set id: 312d9742-6a65-c1cb-e063-6394a90a2e66
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.30b48126-45f3-21fa-e063-6294a90a968f2025-03-19Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDESolco Healthcare U.S., LLCe4024b8a-25cb-4681-9bb4-44a38c74fe4b2025-03-06Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.2d7ddbc2-2afc-473e-a73b-b44ab9fcfaab2025-02-26Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
unii: FZ989GH94E
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.0b4d847a-fcda-df31-e063-6294a90a0c5e2025-02-03Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepacke08b4f49-de9f-490d-b11d-d865439f5fad2025-01-31Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack70f68311-8d1f-4b8e-b8a7-13bc4c17727e2025-01-31Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack86a6ce50-673d-4031-87a0-51965cc1e7952025-01-28Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepacke0a6a289-7dbf-4b24-b815-46dee0d19fdc2025-01-24Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack99c1325b-7152-481d-8a1f-6bf3e2c4808b2025-01-24Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack6b08ccd5-d01f-48f1-80a2-1d121f445d422025-01-23Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack5d84078d-ff2d-4800-b2f4-f1d30c8335bb2025-01-23Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HCL C-IVPHENTERMINE HCL C-IVDirect_Rxe4a2996e-2bfa-376f-e053-2995a90a0ed12025-01-22Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEDirectRxca683656-16a6-9602-e053-2a95a90aa8952025-01-20Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV

Reported adverse events (FAERS/openFDA)#

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