Home NDC 73190-073 Dapagliflozin
Product NDC 73190-073
11-digit product format 731900073
Labeler code 73190
Product ID 73190-073_52a7bfac-a5ec-cba1-e063-6394a90a35ac
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dapagliflozin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AvKARE
Application ANDA211478
Marketing category ANDA
Marketing start 2026-05-25
Substance DAPAGLIFLOZIN
Active strength 10 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 A211478-001 DAPAGLIFLOZIN DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2026-04-06 A211478-002 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 A211478-001 DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2026-04-06 a50c72e98297…2026-08-01 22:54:32 2026-06 A211478-002 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 A211478-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A211478-002 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 10 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 73190-073-30 Dapagliflozin 30 in 1 BOTTLE TABLET, FILM COATED 30 2 73190-073-90 Dapagliflozin 90 in 1 BOTTLE TABLET, FILM COATED 90 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 73190-073-30 73190007330 30 TABLET, FILM COATED in 1 BOTTLE (73190-073-30) 2026-05-25 No No Current 73190-073-90 73190007390 90 TABLET, FILM COATED in 1 BOTTLE (73190-073-90) 2026-05-25 No No Current