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 2 of 9 · 180 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
phentermine and topiramatePHENTERMINE AND TOPIRAMATEPrasco Laboratories876bd763-13fa-481e-b579-c2fc44dbf3c22026-05-18Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackd95e14f7-a46d-47fa-8dab-ee3d8d4c7b6d2026-05-12Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepacke6939fcf-3db2-492a-99ed-a384cdeea7a22026-05-11Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: FZ989GH94E
QsymiaPHENTERMINE AND TOPIRAMATEVivus LLC40dd5602-53da-45ac-bb4b-15789aba40f92026-04-22Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.eae1d7f9-733c-434b-9199-5f7052e541da2026-04-14Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
unii: FZ989GH94E
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack328d6a39-34f4-4b74-a1bf-6ec6005b13222026-04-01Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
Phentermine and Topiramate Extended-ReleasePHENTERMINE AND TOPIRAMATE EXTENDED-RELEASEDr.Reddys Laboratories Inc260c3f90-163d-0bdd-1099-55d18a900e682026-03-31Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.b425840f-380e-42bd-852a-6ee3641977ce2026-03-23Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepacke48feec6-50c9-4ccd-b9da-56956d14c8532026-03-18Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack9155edf8-ea1d-458f-b2a7-e0303fd83cc02026-03-16Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
Phentermine HCL C-IVPHENTERMINE HCL C-IVDirect_Rx4cec0e47-5373-2133-e063-6394a90a20092026-03-13Warnings, Adverse reactionsExact identifier
application number: ANDA040526
rxcui: 803353
unii: 0K2I505OTV
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: FZ989GH94E
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutionsc53bd3c5-01f6-4a21-9e3c-aa4969a01b4b2026-03-04Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine and topiramatePHENTERMINE AND TOPIRAMATETeva Pharmaceuticals, Inc.918df93d-e033-4419-adcc-e21655ef81582026-03-01Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
unii: FZ989GH94E
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.aa9d7161-cda3-4ded-8d5b-424abd1a66812026-02-05Warnings, Adverse reactionsExact identifier
application number: ANDA040526
rxcui: 803353
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackfa5de92d-a5bf-4ae1-8e13-ad827aeebea32026-02-04Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV

Reported adverse events (FAERS/openFDA)#

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