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 7 of 9 · 180 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEDirectRxd27d8379-aa3c-4688-e053-2995a90a44f62025-01-20Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEDIRECT RXc3dda0a4-b428-f3e7-e053-2995a90ad1062025-01-17Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDESUNRISE PHARMACEUTICAL, INC.43024f64-2d77-49a9-80fd-ad07a86c69a32024-12-03Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack50efa498-11c5-41fa-95ac-419fcc10da032024-11-01Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
Clear Eyes Triple ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.1269a1a6-843d-4d08-bb3c-c1f3d2e7080d2024-10-25WarningsExact identifier
unii: FZ989GH94E
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackc8516abe-5ad1-4b76-8e2c-96ee455979cf2024-10-17Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HCLPHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.8fe6b65d-ca61-40f0-90fc-255dfd0756112024-10-15Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.8abf898e-318b-3519-e053-2995a90abf2f2024-09-11Warnings, Adverse reactionsExact identifier
application number: ANDA040526
unii: 0K2I505OTV
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.1fa8798d-c096-5839-e063-6394a90aa28b2024-09-03Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack2bd5487d-10da-4ae0-9105-273e1a5efdcb2024-08-20Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackf427f067-f1a7-4d60-8ce0-90b20e2d4eb52024-08-20Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackf50f5453-e06d-4e39-b868-9bdadf1d8baa2024-08-20Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack53cad049-f1b4-42c0-9cc7-a1c2df75ac582024-08-20Warnings, Adverse reactionsExact identifier
application number: ANDA040526
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackbd7393cb-2b72-4ecd-ba03-801b635b76472024-08-08Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack3c37d637-779d-4097-85ef-e4ce7d0fb86a2024-08-08Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Artificial TearsPOLYVINYL ALCOHOL, POVIDONENuCare Pharmaceuticals,Inc.9c1c4911-908e-3c3c-e053-2995a90abcfc2024-06-14WarningsExact identifier
unii: FZ989GH94E
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack0ca26b58-0a93-4a10-be4d-63a4ad5eecf82024-06-06Warnings, Adverse reactionsExact identifier
application number: ANDA040526
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack7f1c3a5d-dd9b-4441-a483-aa5777f8e40c2024-05-29Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEKVK-Tech, Inc.b963f7bb-fa65-4e28-81c9-282fbe70a6a62024-04-18Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackac8559a0-98fe-4737-b9ec-e36eef3b14fc2024-04-08Warnings, Adverse reactionsExact identifier
application number: ANDA040526
unii: 0K2I505OTV

Reported adverse events (FAERS/openFDA)#

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