Home NDC 31722-782 Afatinib
Product NDC 31722-782
11-digit product format 317220782
Labeler code 31722
Product ID 31722-782_5a8ec67a-afb9-4b6b-e063-6394a90adfc6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Afatinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA210750
Marketing category ANDA
Marketing start 2026-07-14
Substance AFATINIB DIMALEATE
Active strength 30 mg/1
Pharmacologic classes Kinase Inhibitor [EPC], Protein Kinase 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 A210750-001 AFATINIB DIMALEATE AFATINIB DIMALEATE EQ 20MG BASE TABLET / ORAL AB 2026-07-14 A210750-002 AFATINIB DIMALEATE AFATINIB DIMALEATE EQ 30MG BASE TABLET / ORAL AB 2026-07-14 A210750-003 AFATINIB DIMALEATE AFATINIB DIMALEATE EQ 40MG BASE TABLET / ORAL AB 2026-07-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 2026-09-14 22:38:34 2026-08 A210750-001 AFATINIB DIMALEATE EQ 20MG BASE TABLET / ORAL AB 2026-07-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210750-002 AFATINIB DIMALEATE EQ 30MG BASE TABLET / ORAL AB 2026-07-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210750-003 AFATINIB DIMALEATE EQ 40MG BASE TABLET / ORAL AB 2026-07-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210750-001 AFATINIB DIMALEATE EQ 20MG BASE TABLET / ORAL AB 2026-07-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210750-002 AFATINIB DIMALEATE EQ 30MG BASE TABLET / ORAL AB 2026-07-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210750-003 AFATINIB DIMALEATE EQ 40MG BASE TABLET / ORAL AB 2026-07-14 caaa826d4ba7…
Observed Orange Book normalized TE 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 Afatinib
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AFATINIB DIMALEATE 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V1T5K7RZ0B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1430446 Internal RxNorm lookup 1430451 Internal RxNorm lookup 1430455 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 Units Marketing start Sample Exclude flag Status 31722-782-30 31722078230 1 BOTTLE in 1 CARTON (31722-782-30) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2026-07-14 No No Current