Home NDC 68382-913 Erlotinib
Product NDC 68382-913
11-digit product format 683820913
Labeler code 68382
Product ID 68382-913_e34fafdf-2fda-4031-9202-6d7e85925dc1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Erlotinib
Dosage form TABLET
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA213065
Marketing category ANDA
Marketing start 2020-04-30
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 A213065-001 ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2020-04-16 A213065-002 ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2020-04-16 A213065-003 ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB RS 2020-04-16
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 · 111 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 A213065-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2020-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213065-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2020-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213065-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB RS 2020-04-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213065-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2020-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213065-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2020-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213065-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB RS 2020-04-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213065-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2020-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213065-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2020-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213065-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB RS 2020-04-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213065-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2020-04-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213065-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2020-04-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213065-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB RS 2020-04-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213065-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2020-04-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213065-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2020-04-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213065-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB RS 2020-04-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213065-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2020-04-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213065-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2020-04-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213065-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB RS 2020-04-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213065-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2020-04-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213065-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2020-04-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213065-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB RS 2020-04-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213065-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2020-04-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213065-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2020-04-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213065-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB RS 2020-04-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213065-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2020-04-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213065-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2020-04-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213065-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB RS 2020-04-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213065-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2020-04-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213065-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2020-04-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213065-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB RS 2020-04-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213065-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2020-04-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213065-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2020-04-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213065-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB RS 2020-04-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213065-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2020-04-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213065-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2020-04-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213065-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB RS 2020-04-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213065-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2020-04-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213065-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2020-04-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213065-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB RS 2020-04-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213065-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2020-04-16 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 603203 Internal RxNorm lookup 603206 Internal RxNorm lookup 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 68382-913-06 Erlotinib 30 in 1 BOTTLE TABLET 30 3 68382-913-16 Erlotinib 90 in 1 BOTTLE TABLET 90 3 68382-913-30 Erlotinib 10 in 1 BLISTER PACK TABLET 10 3 68382-913-84 Erlotinib 3 in 1 CARTON TABLET 3 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-913 ERLOTINIB TABLET [ZYDUS PHARMACEUTICALS USA INC.] 3 Current NDC, Legacy NDC, 4 package rows 20231011_c35e019d-ec34-4e61-9400-a7ae7913e025.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 · 2 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 68382-913-06 68382091306 30 TABLET in 1 BOTTLE (68382-913-06) 30 tablet 2020-04-30 0000-00-00 No No Current 68382-913-16 68382091316 90 TABLET in 1 BOTTLE (68382-913-16) 90 tablet 2020-04-30 0000-00-00 No No Current 68382-913-30 68382091330 10 in 1 BLISTER PACK Historical 68382-913-84 68382091384 3 BLISTER PACK in 1 CARTON (68382-913-84) / 10 TABLET in 1 BLISTER PACK (68382-913-30) 3 blister pack 2020-04-30 0000-00-00 No No Current