Home NDC 70518-4710 Metformin Hydrochloride
Product NDC 70518-4710
11-digit product format 705184710
Labeler code 70518
Product ID 70518-4710_58c4662f-a448-73c2-e063-6394a90ac1e3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metformin Hydrochloride
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA209694
Marketing category ANDA
Marketing start 2026-07-28
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209694-001 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18 A209694-002 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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.
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 A209694-001 METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209694-002 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209694-001 METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209694-002 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209694-001 METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209694-002 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209694-001 METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209694-002 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209694-001 METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209694-002 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209694-001 METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209694-002 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209694-001 METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209694-002 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209694-001 METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209694-002 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209694-001 METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209694-002 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209694-001 METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209694-002 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209694-001 METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209694-002 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18 a50c72e98297…
Observed Orange Book normalized TE history# 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 1807894 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4710-0 70518471000 50 POUCH in 1 BOX (70518-4710-0) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4710-1) 50 pouch 2026-07-28 No No Current 70518-4710-2 70518471002 100 POUCH in 1 BOX (70518-4710-2) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4710-1) 100 pouch 2026-08-10 No No Current