FDA.reportPublic FDA data

Application 021202

Type
NDA
Sponsor
EMD SERONO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLUCOPHAGE XRMETFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004GLUCOPHAGE XRMETFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL750MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021202-001GLUCOPHAGE XRMETFORMIN HYDROCHLORIDE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2000-10-13
N021202-004GLUCOPHAGE XRMETFORMIN HYDROCHLORIDE750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2003-04-11

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.

Product history page 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021202-001GLUCOPHAGE XR500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2000-10-13f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N021202-004GLUCOPHAGE XR750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2003-04-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021202-001GLUCOPHAGE XR500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2000-10-13e64feba35796…
2022-09-29 23:25 UTC2022-09N021202-004GLUCOPHAGE XR750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2003-04-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021202-001GLUCOPHAGE XR500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2000-10-13cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021202-004GLUCOPHAGE XR750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2003-04-11cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021202-001GLUCOPHAGE XR500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2000-10-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021202-004GLUCOPHAGE XR750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2003-04-11a50c72e98297…

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 1 of 13 · 243 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.d5228e81-9c86-4781-b984-20feaa2ae7792026-09-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECamber Pharmaceuticals, Inc.7cc02a26-5c22-445b-ad8f-3e7570c143d32026-09-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEGranules India Ltd73197cb5-3e23-4ac0-b189-f9bc848bce662026-09-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutionsb6d7edc9-93d6-4480-906d-55c18d0536002026-09-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions64f5b140-7ad8-4c07-bbfc-ae4618afa8502026-09-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.bfd6ec0f-8264-4877-aa6d-f347f53bc4262026-09-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.c568d49f-c040-4f1e-ad36-77b05ab659c32026-08-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.ba0379cb-824e-4798-9ff9-99bcd1bea5cb2026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepackfb296500-55cb-45ce-be0c-59aa2e3d46242026-08-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEScieGen Pharmaceuticals Inc4e4c4ba9-65c6-4273-8f6b-2423ab521dad2026-08-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.073cf6d9-7142-4d8b-898e-174c62a1f76f2026-08-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEQPharma,Inc.5866ca12-a28f-cbe7-e063-6294a90acc692026-08-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEQuallent Pharmaceuticals Health LLC25be863d-490c-47f6-9ad3-c828dc43fbf02026-08-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDERedpharm Drug58bec665-b648-6baf-e063-6394a90a1cbb2026-08-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.e22a8545-86a6-439e-a758-29c4d6ed8bfe2026-08-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepackc1bfc7b5-c7e0-4353-b772-05d463c128862026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.1e8136e0-cc98-41e4-ad4b-a8fc27fb4daa2026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.4d087f00-580b-4b9d-80d9-f97930153e722026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.5d8d654a-9bb4-4c87-ab43-c21c4e8747082026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.583f2a2e-a9d7-f266-e063-6294a90ad0ab2026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METFORMIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0087-6063GLUCOPHAGEMETFORMIN HYDROCHLORIDEBristol-Myers Squibb CompanyNDACurrent
0087-6063GLUCOPHAGEMETFORMIN HYDROCHLORIDEBristol-Myers Squibb CompanyNDACurrent
0087-6064GLUCOPHAGEMETFORMIN HYDROCHLORIDEBristol-Myers Squibb CompanyNDACurrent
0087-6064GLUCOPHAGEMETFORMIN HYDROCHLORIDEBristol-Myers Squibb CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54396SUPPL2018-05-31
54382SUPPL2018-05-31
47946SUPPL2017-04-12
47945SUPPL2017-04-12
47936SUPPL2017-04-11
47935SUPPL2017-04-11
14628SUPPL2008-08-29
27051SUPPL2008-08-28
36336SUPPL2006-11-06
4628SUPPL2006-11-06
42018ORIG2004-06-04
4627SUPPL2004-03-24
4626SUPPL2004-03-24
4625SUPPL2003-04-18
14627SUPPL2003-04-17
4624SUPPL2002-01-08
4623SUPPL2001-04-19
14626ORIG2000-10-13
4622ORIG2000-10-13