Home NDC 72485-217 Erlotinib
Product NDC 72485-217
11-digit product format 724850217
Labeler code 72485
Product ID 72485-217_35e3a161-752e-4479-b27c-3dc8efd3ca9e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Erlotinib hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Armas Pharmaceuticals Inc.
Application ANDA211960
Marketing category ANDA
Marketing start 2019-11-06
Substance ERLOTINIB HYDROCHLORIDE
Active strength 25 mg/1
Pharmacologic classes Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211960-001 ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2019-11-05 A211960-002 ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2019-11-05 A211960-003 ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-11-05
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.
Product history page 1 of 3 · 117 observed 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 2026-02-19 14:30 UTC 2026-02 A211960-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2019-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211960-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2019-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211960-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-11-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211960-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2019-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211960-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2019-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211960-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-11-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211960-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2019-11-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211960-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2019-11-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211960-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-11-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211960-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2019-11-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211960-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2019-11-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211960-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-11-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211960-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2019-11-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211960-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2019-11-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211960-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-11-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211960-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2019-11-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211960-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2019-11-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211960-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-11-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211960-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2019-11-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211960-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2019-11-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211960-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-11-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211960-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2019-11-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211960-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2019-11-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211960-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-11-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211960-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2019-11-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211960-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2019-11-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211960-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-11-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211960-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2019-11-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211960-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2019-11-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211960-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-11-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211960-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2019-11-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211960-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2019-11-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211960-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-11-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211960-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2019-11-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211960-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2019-11-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211960-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-11-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211960-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2019-11-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211960-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2019-11-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211960-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2019-11-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211960-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2019-11-05 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 117 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Erlotinib
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ERLOTINIB HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination DA87705X9K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 603208 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 72485-217-30 Erlotinib 30 in 1 BOTTLE TABLET, FILM COATED 30 1 72485-217-30 Erlotinib 1 in 1 BOX TABLET, FILM COATED 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72485-217 ERLOTINIB (ERLOTINIB HYDROCHLORIDE) TABLET, FILM COATED [ARMAS PHARMACEUTICALS INC.] 1 Current NDC, Legacy NDC, 2 package rows 20191110_53cf8868-cfd8-4c6e-ad9d-3171ff1e4d8c.zip
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72485-217-30 72485021730 1 BOTTLE in 1 BOX (72485-217-30) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2019-11-06 0000-00-00 No No Current