Home NDC 67877-221 Metformin Hydrochloride
Product NDC 67877-221
11-digit product format 678770221
Labeler code 67877
Product ID 67877-221_4fa6bd66-7f2c-4b63-9809-be460cbc2527
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 1000 mg/1
Pharmacologic classes Biguanide [EPC], Biguanides [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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-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 · 123 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 2026-02-19 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…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Metformin Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METFORMIN HYDROCHLORIDE 1000 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 860975 Internal RxNorm lookup 860981 Internal RxNorm lookup 861004 Internal RxNorm lookup 861007 Internal RxNorm lookup 861010 Internal RxNorm 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 67877-221-01 Metformin Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 24 67877-221-05 Metformin Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 24 67877-221-10 Metformin Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 24 67877-221-33 Metformin Hydrochloride 10 in 1 BLISTER PACK TABLET, FILM COATED 10 24 67877-221-38 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 HYDROCHLORIDE ACTIVE INGREDIENT 786Z46389E METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 METFORMIN ACTIVE MOIETY 9100L32L2N METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 METFORMIN ACTIVE MOIETY 9100L32L2N METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 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 [STATE OF FLORIDA DOH CENTRAL PHARMACY] 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 [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 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 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 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 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-221 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
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67877-221-01 67877022101 100 TABLET, FILM COATED in 1 BOTTLE (67877-221-01) 2011-01-31 0000-00-00 No No Current 67877-221-05 67877022105 500 TABLET, FILM COATED in 1 BOTTLE (67877-221-05) 2011-01-31 0000-00-00 No No Current 67877-221-10 67877022110 1000 TABLET, FILM COATED in 1 BOTTLE (67877-221-10) 2011-01-31 0000-00-00 No No Current 67877-221-33 67877022133 10 in 1 BLISTER PACK Historical 67877-221-38 67877022138 10 BLISTER PACK in 1 CARTON (67877-221-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-221-33) 10 blister pack 2011-01-31 0000-00-00 No No Current