Home NDC 67877-218-10 Metformin Hydrochloride
Product NDC 67877-218
Requested package NDC 67877-218-10
11-digit product format 678770218
Labeler code 67877
Product ID 67877-218_0c532cbf-ce0f-4e95-85ca-486993078787
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metformin Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA091184
Marketing category ANDA
Marketing start 2011-01-31
Substance METFORMIN HYDROCHLORIDE
Active strength 850 mg/1
Pharmacologic classes Biguanide [EPC], Biguanides [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091184-001 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 A091184-002 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 A091184-003 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 132 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 c2088c7a36db…2026-09-14 22:38:34 2026-08 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Metformin Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METFORMIN HYDROCHLORIDE 850 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 786Z46389E Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67877-218-01 Metformin Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 24 67877-218-05 Metformin Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 24 67877-218-10 Metformin Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 24 67877-218-33 Metformin Hydrochloride 10 in 1 BLISTER PACK TABLET, FILM COATED 10 24 67877-218-38 Metformin Hydrochloride 10 in 1 CARTON TABLET, FILM COATED 10 24
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METFORMIN HYDROCHLORIDE ACTIVE INGREDIENT 786Z46389E METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] 11 METFORMIN ACTIVE MOIETY 9100L32L2N METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] 11 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] 11 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] 11 POVIDONE INACTIVE INGREDIENT FZ989GH94E METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] 11 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] 11 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] 11 TALC INACTIVE INGREDIENT 7SEV7J4R1U METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] 11 METFORMIN HYDROCHLORIDE ACTIVE INGREDIENT 786Z46389E METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 METFORMIN ACTIVE MOIETY 9100L32L2N METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-218 METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ASCEND LABORATORIES, LLC] 23 Current NDC, Legacy NDC, 5 package rows 20231101_0ff1ba75-3c86-4baf-a6b1-1bb883839866.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 67877-218-10 67877021810 1000 TABLET, FILM COATED in 1 BOTTLE (67877-218-10) 2011-01-31 0000-00-00 No No Current