Home NDC 70518-4710 Metformin Hydrochloride
Product NDC 70518-4710
11-digit product format 705184710
Labeler code 70518
Product ID 70518-4710_57ae80ca-b1b2-d40e-e063-6294a90aa303
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]
Listing certified through 2027-12-31
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 · 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 2026-08-01 22:54:32 2026-06 A209694-001 METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18 a50c72e98297…2026-08-01 22:54:32 2026-06 A209694-002 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL AB2 2024-10-18 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A209694-001 AB2 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A209694-002 AB2 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample 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 0 Current