Metformin HCl

Product NDC
55700-666
11-digit product format
557000666
Labeler code
55700
Product ID
55700-666_28d02393-bb61-4820-b200-633412b0f264
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin HCl
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA090564
Marketing category
ANDA
Marketing start
2018-08-10
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
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55700-666DDiscontinued by firm2026-10-05
excluded packagepackage55700-66655700-666-00DDiscontinued by firm2026-10-05
excluded packagepackage55700-66655700-666-30DDiscontinued by firm2026-10-05
excluded packagepackage55700-66655700-666-60DDiscontinued by firm2026-10-05
excluded packagepackage55700-66655700-666-90DDiscontinued by firm2026-10-05

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 · 9 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…

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…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-666-00EA - Each55700-666963e92a1-21fb-433a-a5dd-47ef1039808512024-10-04
55700-666-30EA - Each55700-666d5c70102-b582-4749-9331-6e77824f119112021-05-05
55700-666-60EA - Each55700-66667aa02e6-0bdc-4570-b1e3-b66dc05f3e0a12021-03-02
55700-666-90EA - Each55700-66679199b15-c1ad-4604-acf8-7369d1c4926a12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-666METFORMIN HCL TABLET [QUALITY CARE PRODUCTS, LLC]9Legacy NDC20241220_9b6bb7ee-4a0a-4e2d-8a6a-1079390aba05.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 3 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions1c046303-993c-4111-ac9a-40a0d97ca6a22024-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions3c607f04-d36f-4cf8-9cc9-7f2af08b40982024-01-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions7cc82387-8bb0-4bee-9967-cb13eab1d8012024-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsd0bc43a4-301f-4002-9b58-bd81dddf27902023-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsa4679179-af2d-4c84-a1c8-ab0870a4585d2023-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HClMETFORMIN HCLA-S Medication Solutions74f18a3e-0f5c-4172-b499-14f229b431c42023-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HClMETFORMIN HCLBryant Ranch Prepack4bdd2faa-2125-4139-b958-196393e31b7e2023-05-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HClMETFORMIN HCLA-S Medication Solutions4e345b8c-57ab-4f09-9cbe-1d255e9354ba2023-03-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC34aa1761-d16f-4bfc-b7fa-bf1b0387e8a32022-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HClMETFORMIN HCLProficient Rx LP53361a39-cb69-483b-a4be-3a4753bf1ba62022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LPd51f3618-4166-4925-8994-968a653ebc462022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP5f243894-bda3-4fa9-97e4-209dcb389dee2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HClMETFORMIN HCLBryant Ranch Prepack1f8833f9-1232-4aa7-a0d4-04a9f87dc2f02021-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEEpic Pharma, LLC8c1848f9-c113-4552-b6ef-715e72630ad92019-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEMetcure Pharmaceuticals, Inc.5df6adc9-79fd-66ef-e053-2991aa0a75ce2018-01-22Boxed warning, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HClMETFORMIN HCLAscend Laboratories, LLC2d98aea3-35ba-447a-b88f-a5a20b612b2f2017-02-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-666-305570006663030 TABLET in 1 BOTTLE (55700-666-30) 30 tablet2021-04-210000-00-00NoNoCurrent
55700-666-605570006666060 TABLET in 1 BOTTLE (55700-666-60) 60 tablet2020-12-100000-00-00NoNoCurrent
55700-666-905570006669090 TABLET in 1 BOTTLE (55700-666-90) 90 tablet2022-06-230000-00-00NoNoCurrent