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 9 of 9 · 180 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack707af68e-1630-4f86-87ba-1a643d2b4ef92023-10-09Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack83802088-f4fc-4b34-9268-d63fb2ad16552023-09-27Warnings, Adverse reactionsExact identifier
application number: ANDA040526
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEAsclemed USA, Inc.22683183-a828-47a4-9e52-38175d7c6f212023-09-01Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: H3R47K3TBD
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: H3R47K3TBD
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: H3R47K3TBD
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEProficient Rx LPb14a8f6a-a1c6-4104-80f2-0fa35320d04c2023-05-01Warnings, Adverse reactionsExact identifier
application number: ANDA040526
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.f938b0ab-606e-8b21-e053-6294a90a4f4c2023-04-13Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEProficient Rx LP5e1cc734-5d5c-429e-8b4c-4401a01cfba22023-04-01Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutions8c7c1391-bfd1-48f9-b249-9729fe648b892023-02-04Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEProficient Rx LP28fda2ce-d445-47ce-8764-bf113b5db5b32022-11-01Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEProficient Rx LPb3c48b3c-fab7-4ea4-93b0-b108979e9da32022-04-01Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEProficient Rx LP5c1f88ba-d7d6-4b48-b951-c5e65d87e8742022-03-01Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEAsclemed USA, Inc.de76ed27-ac43-4923-b73f-461d33941f6b2020-10-30Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEProficient Rx LP3a3259ec-ded3-427f-843d-928d130de3da2020-03-01Adverse reactionsExact identifier
unii: 0K2I505OTV
PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEEpic Pharma, LLC06573bd8-67b4-4478-8325-aa6be25787cb2019-11-22Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEProficient Rx LPf2da0b5a-c7d6-48c3-98e9-7c611eb6ff7e2019-11-01Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
PhenterminePHENTERMINE HYDROCHLORIDEAurolife Pharma, LLC737eef3b-9a6b-4ab3-a25c-49d84d2a01972019-01-04Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEKVK-TECH, Inc.ff620c0b-aa99-4f63-9526-d094cedc8d192018-12-20Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEElite Laboratories, Inc.0b7ad9c0-9e1e-4a69-802b-28f44267e34d2017-04-14Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV

Reported adverse events (FAERS/openFDA)#

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