Metformin Hydrochloride

Product NDC
68788-7889
Requested package NDC
68788-7889-9
11-digit product format
687887889
Labeler code
68788
Product ID
68788-7889_59ab8edd-3099-4b51-b36e-dd4faab288c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA209882
Marketing category
ANDA
Marketing start
2021-04-23
Marketing end
0000-00-00
Substance
METFORMIN HYDROCHLORIDE
Active strength
1000 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68788-788968788-7889-9DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A209882-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2018-08-27
A209882-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2018-08-27
A209882-003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2018-08-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209882-001AB
A209882-002AB
A209882-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209882-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2018-08-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209882-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2018-08-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209882-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2018-08-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209882-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2018-08-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209882-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2018-08-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209882-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2018-08-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A209882-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2018-08-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209882-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2018-08-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209882-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2018-08-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209882-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2018-08-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209882-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2018-08-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209882-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2018-08-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209882-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2018-08-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209882-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2018-08-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209882-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2018-08-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209882-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2018-08-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209882-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2018-08-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209882-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2018-08-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209882-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2018-08-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209882-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2018-08-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209882-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2018-08-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209882-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2018-08-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209882-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2018-08-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209882-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2018-08-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209882-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2018-08-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209882-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2018-08-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209882-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2018-08-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209882-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2018-08-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A209882-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2018-08-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A209882-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2018-08-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209882-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2018-08-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209882-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2018-08-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209882-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2018-08-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209882-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2018-08-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209882-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2018-08-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209882-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2018-08-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209882-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2018-08-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209882-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2018-08-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209882-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2018-08-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209882-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2018-08-278072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209882-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209882-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209882-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209882-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209882-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209882-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209882-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209882-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209882-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209882-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209882-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209882-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209882-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209882-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209882-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209882-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209882-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209882-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209882-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209882-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209882-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209882-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209882-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209882-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209882-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209882-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209882-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209882-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209882-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209882-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209882-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209882-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209882-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209882-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209882-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209882-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209882-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209882-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209882-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209882-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7889-1EA - Each68788-7889551fb94c-a93d-4c0f-bc7a-f6b4150a76a412021-06-02
68788-7889-3EA - Each68788-7889bdbe3ab4-63ac-426c-bb0f-299452d71f9a12021-06-02
68788-7889-6EA - Each68788-7889130de42a-ee6f-48ca-ae61-bd0f7e52fb7012022-11-07
68788-7889-7EA - Each68788-788917f116f9-8699-49d9-8882-e0931b4854ff12021-06-02
68788-7889-8EA - Each68788-7889ba99deff-5dcf-4919-b9b3-cb85b441987612021-06-02
68788-7889-9EA - Each68788-7889dc539f55-ece2-47c7-bea6-93287ec00fdf12021-06-02

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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsf4fc759a-057e-4b5d-b8ab-13bc5eeb24e42026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions400ff9dc-9789-44ac-afb5-730b632a16672026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDELaurus Labs Limitedc3dfa8a1-d10a-4a1a-8eba-5f4e2a5a29492026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepackbe023bca-511e-4801-bd2b-e30dd14087722026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HCLMETFORMIN HCLDirect_Rx498ac5fc-14be-d36a-e063-6394a90a30122026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions8c248958-6c01-455e-89f5-959facb272ed2026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsf59ceea4-a84a-4082-8e73-7c6f340c28d62026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions192970d3-826a-4b69-a525-9742794dc19c2026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.ca71c133-6c38-4b9e-80af-1949634157f42026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENorthwind Health Company, LLC0178b9dd-bafa-9e81-e063-6294a90a88b02026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.bfd6ec0f-8264-4877-aa6d-f347f53bc4262025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECoupler LLC3eeee3b7-188a-05a0-e063-6294a90a18532025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.e1ebb146-acfd-4301-a79c-f5bb243f85752025-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.33155746-c2ef-12f4-e063-6294a90a039c2025-04-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.0f251f2c-97f3-4048-84f2-81fea03685aa2025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepack286d959a-51cb-4dbd-a3e8-1ea2f00b54c72024-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepacked6e6f87-ddd7-4c9d-a263-47154d3a94782024-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsc2783b59-7b20-4d4c-a3ca-03ed60dcf2c32024-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions2be73d5e-7682-4ad3-831b-8c1ea73e38de2024-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7889-96878878890990 TABLET, FILM COATED in 1 BOTTLE (68788-7889-9) 2021-04-230000-00-00NoNoCurrent