FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
63629-6530
11-digit product format
636296530
Labeler code
63629
Product ID
63629-6530_2a03ea4e-86dd-4a9e-8a4d-208d2205aca2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077095
Marketing category
ANDA
Marketing start
2005-01-14
Marketing end
0000-00-00
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Biguanide [EPC],Biguanides [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-6530DDiscontinued by firm2026-07-31
excluded packagepackage63629-653063629-6530-1DDiscontinued by firm2026-07-31
excluded packagepackage63629-653063629-6530-2DDiscontinued by firm2026-07-31
excluded packagepackage63629-653063629-6530-3DDiscontinued by firm2026-07-31
excluded packagepackage63629-653063629-6530-4DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077095-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-01-14
A077095-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-01-14
A077095-003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-01-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077095-001AB
A077095-002AB
A077095-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077095-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-01-14a50c72e98297…
2026-08-01 22:54:322026-06A077095-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-01-14a50c72e98297…
2026-08-01 22:54:322026-06A077095-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-01-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077095-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077095-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A077095-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAurobindo Pharma Limited4ac6d01a-af26-44e7-ae2e-3618de0080aa2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAurobindo Pharma Limitedfc466c46-abaa-4675-aef2-4b1a1adfd9122026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.5d8d654a-9bb4-4c87-ab43-c21c4e8747082026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepackfb296500-55cb-45ce-be0c-59aa2e3d46242026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.073cf6d9-7142-4d8b-898e-174c62a1f76f2026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs0448c618-2f0d-4ed3-866f-74b413cf902d2026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions1d7556eb-82b4-4085-b0b1-dc061b216feb2026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENorthwind Health Company, LLCdb113f46-6fac-9005-e053-2995a90a017a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3d450933-8d9d-27de-e063-6294a90ae6d92025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3ab4efb6-bd30-2583-e063-6294a90a415b2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions23aa50c5-28fe-4322-b5c6-1f1c48409b162025-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC390c3bdf-bfaf-203e-e063-6394a90a7d202025-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs23aa0072-365c-4d13-9aa7-ae23f7e00ee42024-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions1a7f7ef3-a94b-4ff6-a9f2-f5de4a99c7f62024-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsafb183f6-a13c-4f00-82d5-9fe336173d342024-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP1b9b6db9-1bac-4252-a03c-18dc0271f05f2023-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-6530-12020-10-16C16284748780-19d75b9d0-5653-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
63629-6530-22020-10-16C16284748780-19d75b9d0-5653-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
63629-6530-32020-10-16C16284748780-19d75b9d0-5653-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
63629-6530-42020-10-16C16284748780-19d75b9d0-5653-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
63629-6530-12020-01-31C16284748780-19d75b9d0-5653-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
63629-6530-22020-01-31C16284748780-19d75b9d0-5653-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
63629-6530-32020-01-31C16284748780-19d75b9d0-5653-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
63629-6530-42020-01-31C16284748780-19d75b9d0-5653-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-6530-16362965300190 TABLET, FILM COATED in 1 BOTTLE (63629-6530-1) 2015-07-270000-00-00NoNoCurrent
63629-6530-26362965300260 TABLET, FILM COATED in 1 BOTTLE (63629-6530-2) 2015-07-270000-00-00NoNoCurrent
63629-6530-36362965300330 TABLET, FILM COATED in 1 BOTTLE (63629-6530-3) 2015-07-270000-00-00NoNoCurrent
63629-6530-463629653004180 TABLET, FILM COATED in 1 BOTTLE (63629-6530-4) 2015-07-270000-00-00NoNoCurrent