Home NDC 0480-3528 DAPAGLIFLOZIN
Product NDC 0480-3528
11-digit product format 004803528
Labeler code 0480
Product ID 0480-3528_64caba8e-fb3b-4238-96f1-9155c22bf021
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DAPAGLIFLOZIN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals, Inc.
Application ANDA211541
Marketing category ANDA
Marketing start 2026-04-08
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 42 .
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 A211541-001 DAPAGLIFLOZIN DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2026-04-06 A211541-002 DAPAGLIFLOZIN DAPAGLIFLOZIN 10MG TABLET / ORAL AB 2026-04-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A211541-001 PC 2026-10-03 A211541-002 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 2026-08-18 06:07:40 2026-07 A211541-001 DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2026-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211541-002 DAPAGLIFLOZIN 10MG TABLET / ORAL AB 2026-04-06 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211541-001 DAPAGLIFLOZIN 5MG TABLET / ORAL AB 2026-04-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211541-002 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 2026-08-18 06:07:40 2026-07 A211541-001 AB 1 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211541-002 AB 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211541-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211541-002 AB 1 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-18 06:07:40 2026-07 A211541-001 PC 2026-10-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211541-002 PC 2026-10-03 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211541-001 PC 2026-10-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211541-002 PC 2026-10-03 a50c72e98297…
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 0480-3528-05 DAPAGLIFLOZIN 500 in 1 BOTTLE TABLET, FILM COATED 500 5 0480-3528-56 DAPAGLIFLOZIN 30 in 1 BOTTLE TABLET, FILM COATED 30 5 0480-3528-98 DAPAGLIFLOZIN 90 in 1 BOTTLE TABLET, FILM COATED 90 5
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0480-3528-05 00480352805 500 TABLET, FILM COATED in 1 BOTTLE (0480-3528-05) 2026-05-14 No No Current 0480-3528-56 00480352856 30 TABLET, FILM COATED in 1 BOTTLE (0480-3528-56) 2026-04-08 No No Current 0480-3528-98 00480352898 90 TABLET, FILM COATED in 1 BOTTLE (0480-3528-98) 2026-04-27 No No Current