Home NDC 69539-092 Erlotinib Hydrochloride
Product NDC 69539-092
11-digit product format 695390092
Labeler code 69539
Product ID 69539-092_a94a0c14-c037-49e2-80a0-9e273d538c58
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Erlotinib Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler MSN LABORATORIES PRIVATE LIMITED
Application ANDA214366
Marketing category ANDA
Marketing start 2021-05-11
Marketing end 0000-00-00
Substance ERLOTINIB HYDROCHLORIDE
Active strength 150 mg/1
Pharmacologic classes Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 69539-092 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69539-092 69539-092-30 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 A214366-001 ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2021-05-10 A214366-002 ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2021-05-10 A214366-003 ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2021-05-10
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 · 99 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 A214366-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2021-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214366-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2021-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214366-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2021-05-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214366-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2021-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214366-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2021-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214366-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2021-05-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214366-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2021-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214366-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2021-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214366-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2021-05-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214366-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2021-05-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214366-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2021-05-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214366-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2021-05-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214366-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2021-05-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214366-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2021-05-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214366-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2021-05-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214366-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2021-05-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214366-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2021-05-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214366-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2021-05-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214366-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2021-05-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214366-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2021-05-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214366-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2021-05-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214366-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2021-05-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214366-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2021-05-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214366-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2021-05-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214366-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2021-05-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214366-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2021-05-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214366-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2021-05-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214366-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2021-05-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214366-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2021-05-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214366-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2021-05-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214366-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2021-05-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214366-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2021-05-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214366-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2021-05-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214366-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2021-05-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214366-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2021-05-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214366-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2021-05-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214366-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2021-05-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214366-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2021-05-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214366-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2021-05-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214366-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2021-05-10 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 99 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69539-092 ERLOTINIB HYDROCHLORIDE TABLET, FILM COATED [MSN LABORATORIES PRIVATE LIMITED] 1 Legacy NDC 20210513_a94a0c14-c037-49e2-80a0-9e273d538c58.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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69539-092-30 69539009230 1 BOTTLE in 1 CARTON (69539-092-30) > 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2021-05-11 0000-00-00 No No Current