Home NDC 70771-1714 Dapagliflozin
Product NDC 70771-1714
11-digit product format 707711714
Labeler code 70771
Product ID 70771-1714_e0ce1921-cd6e-4663-acd0-ae34bd8222fa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dapagliflozin
Dosage form TABLET
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA211582
Marketing category ANDA
Marketing start 2026-04-06
Substance DAPAGLIFLOZIN
Active strength 5 mg/1
Pharmacologic classes 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 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 A211582-001 DAPAGLIFLOZIN DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2026-04-06 A211582-002 DAPAGLIFLOZIN DAPAGLIFLOZIN 10MG TABLET / ORAL AB 2026-04-06
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 A211582-001 DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2026-04-06 a50c72e98297…2026-08-01 22:54:32 2026-06 A211582-002 DAPAGLIFLOZIN 10MG TABLET / ORAL AB 2026-04-06 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 A211582-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A211582-002 AB 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 Dapagliflozin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DAPAGLIFLOZIN 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1ULL0QJ8UC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1488569 Internal RxNorm lookup 1488574 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 70771-1714-3 Dapagliflozin 30 in 1 BOTTLE TABLET 30 6 70771-1714-9 Dapagliflozin 90 in 1 BOTTLE TABLET 90 6
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70771-1714-3 70771171403 30 TABLET in 1 BOTTLE (70771-1714-3) 30 tablet 2026-04-06 No No Current 70771-1714-9 70771171409 90 TABLET in 1 BOTTLE (70771-1714-9) 90 tablet 2026-04-06 No No Current