Home NDC 84677-020 Dapagliflozin and Metformin Hydrochloride
Product NDC 84677-020
11-digit product format 846770020
Labeler code 84677
Product ID 84677-020_54026404-8dfd-12f8-e063-6394a90a9a60
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dapagliflozin and Metformin Hydrochloride
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA211491
Marketing category ANDA
Marketing start 2026-03-16
Substance DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Active strength 5; 1000 mg/1; mg/1
Pharmacologic classes Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
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 A211491-001 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 A211491-002 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 A211491-003 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A211491-001 PC 2026-10-03 A211491-002 PC 2026-10-03 A211491-003 PC 2026-10-03
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 A211491-001 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211491-002 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211491-003 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211491-001 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211491-002 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211491-003 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211491-001 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211491-002 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211491-003 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity 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 Dapagliflozin and Metformin Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DAPAGLIFLOZIN 5 mg/1 METFORMIN HYDROCHLORIDE 1000 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 786Z46389E Internal UNII lookup 1ULL0QJ8UC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1593058 Internal RxNorm lookup 1593068 Internal RxNorm lookup 1593070 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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 84677-020-60 84677002060 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (84677-020-60) 2026-03-16 No No Current