Home NDC 72789-551 METFORMIN HYDROCHLORIDE
Product NDC 72789-551
11-digit product format 727890551
Labeler code 72789
Product ID 72789-551_4cea555b-4105-0f82-e063-6394a90a90a9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METFORMIN HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA213320
Marketing category ANDA
Marketing start 2025-08-25
Substance METFORMIN HYDROCHLORIDE
Active strength 1000 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 43 .
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 A213320-001 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2021-12-03 A213320-002 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2021-12-03 A213320-003 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2021-12-03
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 3 · 105 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 2026-09-14 22:38:34 2026-08 A213320-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2021-12-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213320-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2021-12-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213320-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2021-12-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213320-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2021-12-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213320-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2021-12-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213320-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2021-12-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213320-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2021-12-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213320-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2021-12-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213320-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2021-12-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213320-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2021-12-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213320-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2021-12-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213320-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2021-12-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213320-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2021-12-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213320-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2021-12-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213320-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2021-12-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213320-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2021-12-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213320-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2021-12-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213320-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2021-12-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213320-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2021-12-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213320-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2021-12-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213320-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2021-12-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213320-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2021-12-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213320-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2021-12-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213320-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2021-12-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213320-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2021-12-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213320-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2021-12-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213320-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2021-12-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213320-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2021-12-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213320-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2021-12-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213320-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2021-12-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213320-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2021-12-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213320-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2021-12-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213320-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2021-12-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213320-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2021-12-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213320-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2021-12-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213320-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2021-12-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213320-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2021-12-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213320-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2021-12-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213320-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2021-12-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213320-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2021-12-03 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 105 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 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861004 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 72789-551-30 METFORMIN HYDROCHLORIDE 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 3 72789-551-42 METFORMIN HYDROCHLORIDE 42 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 42 3 72789-551-60 METFORMIN HYDROCHLORIDE 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 3 72789-551-90 METFORMIN HYDROCHLORIDE 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 3 72789-551-93 METFORMIN HYDROCHLORIDE 180 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 180 3
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 2 of 2 · 24 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE NuCare Pharmaceuticals, Inc. 289dc8ec-42c8-1d09-e063-6394a90a97f0 2024-12-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213320 application number: ANDA213320 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE NuCare Pharmaceuticals,Inc. 0710e208-5b2c-3c72-e063-6394a90a4dac 2024-09-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213320 application number: ANDA213320 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE Bryant Ranch Prepack 6a9ab61a-a5d0-41ef-b528-59eac6b4cfe6 2024-08-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213320 application number: ANDA213320 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE NuCare Pharmaceuticals,Inc. 1182bf60-3578-a0ed-e063-6394a90aa50f 2024-02-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213320 application number: ANDA213320
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72789-551-30 72789055130 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-551-30) 2026-03-13 No No Current 72789-551-42 72789055142 42 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-551-42) 2026-02-26 No No Current 72789-551-60 72789055160 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-551-60) 2026-02-26 No No Current 72789-551-90 72789055190 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-551-90) 2026-02-26 No No Current 72789-551-93 72789055193 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-551-93) 2026-02-26 No No Current