Metformin Hydrochloride Tablets, USP

Manufacturer
Granules Pharmaceuticals Inc
Effective date
2024-08-27
Label type
BULK INGREDIENT
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 20:55:52

Label at a glance#

ProductMetformin Hydrochloride
Active ingredientMETFORMIN HYDROCHLORIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

70010-063-1570010-063-1570010-064-1670010-064-1670010-065-1770010-065-17metformin-1000mg-label2-jpgmetformin-1000mg-label2-jpgmetformin-1000mg-label1-jpgmetformin-1000mg-label1-jpgmetformin-1000mg-label-jpgmetformin-1000mg-label-jpgmetformin-850mg-label2-jpgmetformin-850mg-label2-jpgmetformin-850mg-label1-jpgmetformin-850mg-label1-jpgmetformin-500mg-label2-jpgmetformin-500mg-label2-jpgmetformin-500mg-label1metformin-500mg-label1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-063-01EA - Each70010-063dd69ac30-ab57-471b-a990-fe8c539e204e12020-05-08
70010-063-05EA - Each70010-063be07ad10-0344-4c69-9e3f-f4136ad26c5912020-05-08
70010-063-09EA - Each70010-0637d9c517c-19dc-4a72-95cc-d7f4059f87c412021-04-08
70010-063-10EA - Each70010-063cf0824c7-284a-499a-8dd0-6edc240cbdee12020-05-08
70010-064-01EA - Each70010-064f30af531-eb4f-471d-b7d6-23d61fd3fb6012020-05-08
70010-064-05EA - Each70010-064b66f1b02-cf4f-400f-80fa-3a62c4b0298412020-05-08
70010-064-09EA - Each70010-0642fc086c8-7957-4d32-885b-af148a4d4ee812021-04-08
70010-064-10EA - Each70010-06412355609-eb58-4885-bbc6-3b122384e23012020-05-08
70010-065-01EA - Each70010-065f7a485d2-9944-4858-a846-d3814bd9d7c012020-05-08
70010-065-05EA - Each70010-06549c99d4f-cd4c-4603-8e38-faa53035fc6512020-05-08
70010-065-09EA - Each70010-06591136504-88b5-4bb6-aa25-9a85251525c812021-04-08
70010-065-10EA - Each70010-06592dfbca6-c6a2-466d-bedc-c4472c33a20012020-05-08

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70010-06370010-063-15
70010-06470010-064-16
70010-06570010-065-17

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090564-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-04-22
A090564-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-04-22
A090564-003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE1GMTABLET / ORALABRS2010-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090564-001AB
A090564-002AB
A090564-003AB

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.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090564-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-04-2284e616aacf4f…
2026-09-14 22:38:342026-08A090564-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-04-2284e616aacf4f…
2026-09-14 22:38:342026-08A090564-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALABRS2010-04-2284e616aacf4f…
2026-08-18 06:07:402026-07A090564-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-04-22caaa826d4ba7…
2026-08-18 06:07:402026-07A090564-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-04-22caaa826d4ba7…
2026-08-18 06:07:402026-07A090564-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALABRS2010-04-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090564-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090564-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090564-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALABRS2010-04-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090564-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090564-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090564-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALABRS2010-04-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A090564-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090564-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090564-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALABRS2010-04-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090564-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-04-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090564-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-04-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090564-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALABRS2010-04-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090564-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-04-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090564-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-04-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090564-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALABRS2010-04-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090564-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-04-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090564-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-04-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090564-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALABRS2010-04-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090564-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-04-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090564-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-04-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090564-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALABRS2010-04-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090564-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-04-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090564-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-04-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090564-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALABRS2010-04-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090564-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-04-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090564-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-04-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090564-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALABRS2010-04-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090564-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-04-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A090564-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-04-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A090564-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALABRS2010-04-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090564-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-04-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090564-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-04-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090564-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALABRS2010-04-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090564-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-04-22301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090564-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090564-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A090564-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A090564-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090564-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090564-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090564-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090564-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090564-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090564-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090564-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090564-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090564-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090564-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090564-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090564-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090564-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090564-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090564-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090564-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090564-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090564-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090564-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090564-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090564-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090564-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090564-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090564-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090564-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090564-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090564-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090564-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090564-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090564-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090564-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090564-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090564-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090564-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090564-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090564-001AB1301d65b070ca…

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEGranules Pharmaceuticals Inc.2387a618-24d8-4813-aa83-9114edb353742026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 70010-064
ndc (product): 70010-065
ndc (product): 70010-063

Reported adverse events (FAERS/openFDA)#

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