FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
70518-4710
Requested package NDC
70518-4710-0
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209694-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB22024-10-18
A209694-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB22024-10-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A209694-001AB2
A209694-002AB2

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A209694-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB22024-10-18a50c72e98297…
2026-08-01 22:54:322026-06A209694-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB22024-10-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209694-001AB21a50c72e98297…
2026-08-01 22:54:322026-06A209694-002AB21a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.e22a8545-86a6-439e-a758-29c4d6ed8bfe2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209694
application number: ANDA209694
ndc (package): 70518-4710-0
ndc (product): 70518-4710
ndc11 (package): 70518471000
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAurobindo Pharma Limitedef77c7dd-a65f-4adc-a0d9-a93779b459a02026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209694
application number: ANDA209694

Additional Listing Data#

Finished product
Yes
Brand name base
Metformin Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE1000 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
786Z46389EInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e22a8545-86a6-439e-a758-29c4d6ed8bfeAvailable on FDA.report

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
70518-4710-07051847100050 POUCH in 1 BOX (70518-4710-0) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4710-1)50 pouch2026-07-280Current