Home NDC 71335-2245 METFORMIN HYDROCHLORIDE
Product NDC 71335-2245
11-digit product format 713352245
Labeler code 71335
Product ID 71335-2245_703ac447-917b-4816-b59f-09ef358cfb92
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metformin hydrochloride
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA213320
Marketing category ANDA
Marketing start 2023-01-19
Marketing end 2027-03-31
Substance METFORMIN HYDROCHLORIDE
Active strength 850 mg/1
Pharmacologic classes Biguanide [EPC], Biguanides [CS]
NDC exclude flag No
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 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 · 108 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 A213320-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2021-12-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 A213320-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2021-12-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 A213320-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2021-12-03 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 108 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 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 71335-2245-1 METFORMIN HYDROCHLORIDE 60 in 1 BOTTLE TABLET 60 101 71335-2245-2 METFORMIN HYDROCHLORIDE 30 in 1 BOTTLE TABLET 30 101 71335-2245-3 METFORMIN HYDROCHLORIDE 120 in 1 BOTTLE TABLET 120 101 71335-2245-4 METFORMIN HYDROCHLORIDE 90 in 1 BOTTLE TABLET 90 101 71335-2245-5 METFORMIN HYDROCHLORIDE 100 in 1 BOTTLE TABLET 100 101 71335-2245-6 METFORMIN HYDROCHLORIDE 180 in 1 BOTTLE TABLET 180 101
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-2245 METFORMIN HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 100 Current NDC, 6 package rows 20230927_1e7ab8da-4ece-499c-b0fb-34e37d991c1c.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 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 Units Marketing start Marketing end Sample Exclude flag Status 71335-2245-1 71335224501 60 TABLET in 1 BOTTLE (71335-2245-1) 60 tablet 2023-09-25 2027-03-31 No No Historical 71335-2245-2 71335224502 30 TABLET in 1 BOTTLE (71335-2245-2) 30 tablet 2023-09-25 2027-03-31 No No Historical 71335-2245-3 71335224503 120 TABLET in 1 BOTTLE (71335-2245-3) 120 tablet 2023-09-25 2027-03-31 No No Historical 71335-2245-4 71335224504 90 TABLET in 1 BOTTLE (71335-2245-4) 90 tablet 2023-09-25 2027-03-31 No No Historical 71335-2245-5 71335224505 100 TABLET in 1 BOTTLE (71335-2245-5) 100 tablet 2023-09-25 2027-03-31 No No Historical 71335-2245-6 71335224506 180 TABLET in 1 BOTTLE (71335-2245-6) 180 tablet 2023-09-25 2027-03-31 No No Historical