FDA.reportPublic FDA data

NDC 68071-4919-07 - 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
68071-4919
Requested NDC
68071-4919-07
Package NDCs from labels
68071-4919-3, 68071-4919-5, 68071-4919-7, 68071-4919-07
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-09-11
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.2024-09-11HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-12-06These highlights do not include all the information needed to use PHENTERMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PHENTERMINE HYDROCHLORIDE TABLETS. PHENTERMINE HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1959
2023-01-30These highlights do not include all the information needed to use PHENTERMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PHENTERMINE HYDROCHLORIDE TABLETS. PHENTERMINE HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1959
2021-02-18These highlights do not include all the information needed to use PHENTERMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PHENTERMINE HYDROCHLORIDE TABLETS. PHENTERMINE HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1959
2021-01-29These highlights do not include all the information needed to use PHENTERMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PHENTERMINE HYDROCHLORIDE TABLETS. PHENTERMINE HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4919-3Phentermine Hydrochloride30 in 1 BOTTLETABLET305
68071-4919-5Phentermine Hydrochloride56 in 1 BOTTLETABLET565
68071-4919-7Phentermine Hydrochloride7 in 1 BOTTLETABLET75

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4919PHENTERMINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 3 package rows20240913_8abf898e-318b-3519-e053-2995a90abf2f.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 5 of 9 · 180 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
unii: FZ989GH94E
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.6749c074-52a1-4d74-96a2-d9302b3c49a12025-10-20Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.68fcc228-5f06-4ece-94f3-59b5b33c33252025-10-20Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.4000c00f-aa6c-4ea5-af0e-149dde3c74db2025-10-20Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f115ad6d-cf62-40e7-89d1-6183a9b5071f2025-10-17Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.378d863a-6977-4543-ae50-c3684a6abd9b2025-10-15Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.abf702d6-6f94-48dc-ad23-c52fd74e83a82025-10-15Warnings, Adverse reactionsExact identifier
application number: ANDA040526
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.2abc445c-daa8-7326-e054-00144ff88e882025-10-15Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutions5234cabd-6b3e-404d-a0cd-256ee5fcc8f12025-10-08Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutions7198d596-3e1c-49d5-91aa-c62fa2e2b8002025-10-08Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: FZ989GH94E
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack640d71d8-45c9-42fb-ad96-2f3ac60afc9c2025-09-05Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackfe78b5b4-47bf-484b-ab37-e0d7de6fad572025-09-05Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.e4508aa9-1e7a-4af7-829e-5fa353c92f5e2025-08-22Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEChartwell RX, LLCd70f0be3-fcc7-4a1d-9a82-bb1bb21a15282025-08-19Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEMartek Pharmacal Co.c4e9ec2e-4660-4442-93d7-c05a16e137b52025-07-23Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEMartek Pharmacal Co.12699287-9ca9-07b3-e063-6294a90af21a2025-07-23Warnings, Adverse reactionsExact identifier
application number: ANDA040526
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEMartek Pharmacal Co.1fe86035-19ef-4944-ad81-c0167a8e7fec2025-07-23Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEMartek Pharmacal Co.1a8b3c4a-f7fe-5cc9-e063-6394a90a90dd2025-07-21Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.02b8f684-b1ca-4ab7-9567-bcacc6a927792025-07-14Warnings, Adverse reactionsExact identifier
application number: ANDA040526
ndc (product): 53489-676
rxcui: 803353
spl id: 39e24c57-7266-2bf6-e063-6294a90afdd1
spl set id: 02b8f684-b1ca-4ab7-9567-bcacc6a92779
unii: 0K2I505OTV

Reported adverse events (FAERS/openFDA)#

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