Erlotinib Tablets
- Manufacturer
- Zydus Lifesciences Limited
- Effective date
- 2024-11-28
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 21:18:25
Label at a glance#
Label contents#
Full prescribing information#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 603203 | erlotinib 100 MG Oral Tablet | PSN | 3 |
| 603206 | erlotinib 150 MG Oral Tablet | PSN | 3 |
| 603208 | erlotinib 25 MG Oral Tablet | PSN | 3 |
| 603203 | erlotinib 100 MG Oral Tablet | SCD | 3 |
| 603206 | erlotinib 150 MG Oral Tablet | SCD | 3 |
| 603208 | erlotinib 25 MG Oral Tablet | SCD | 3 |
| 603208 | erlotinib (as erlotinib hydrochloride) 25 MG Oral Tablet | SY | 3 |
| 603203 | erlotinib 100 MG (equivalent to erlotinib HCl 109.3 MG) Oral Tablet | SY | 3 |
| 603206 | erlotinib 150 MG (equivalent to erlotinib HCl 163.9 MG) Oral Tablet | SY | 3 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ERLOTINIB Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bd23d1a5-e4ff-4f92-da3b-5034c014ad1a | Product name | 8 | 20250331 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70771-1521-2 | Erlotinib | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 3 | |
| 70771-1521-3 | Erlotinib | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 3 | |
| 70771-1521-7 | Erlotinib | 3 in 1 CARTON | TABLET, FILM COATED | 3 | 3 | |
| 70771-1521-9 | Erlotinib | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 3 | |
| 70771-1522-2 | Erlotinib | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 3 | |
| 70771-1522-3 | Erlotinib | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 3 | |
| 70771-1522-7 | Erlotinib | 3 in 1 CARTON | TABLET, FILM COATED | 3 | 3 | |
| 70771-1522-9 | Erlotinib | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 3 | |
| 70771-1523-2 | Erlotinib | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 3 | |
| 70771-1523-3 | Erlotinib | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 3 | |
| 70771-1523-7 | Erlotinib | 3 in 1 CARTON | TABLET, FILM COATED | 3 | 3 | |
| 70771-1523-9 | Erlotinib | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70771-1521 | ERLOTINIB TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] | 3 | Current NDC, Legacy NDC, 4 package rows | 20241201_daaa1329-3a3f-439c-b13d-b301daa234d4.zip |
| 70771-1522 | ERLOTINIB TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] | 3 | Current NDC, Legacy NDC, 4 package rows | 20241201_daaa1329-3a3f-439c-b13d-b301daa234d4.zip |
| 70771-1523 | ERLOTINIB TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] | 3 | Current NDC, Legacy NDC, 4 package rows | 20241201_daaa1329-3a3f-439c-b13d-b301daa234d4.zip |
Products#
Every source-derived product name is available through these pages.
- Erlotinib
- ERLOTINIB HYDROCHLORIDE
- CROSPOVIDONE (120 .MU.M)
- HYPROMELLOSE 2910 (6 MPA.S)
- LACTOSE MONOHYDRATE
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE 101
- MICROCRYSTALLINE CELLULOSE 102
- POLYETHYLENE GLYCOL 4000
- SILICON DIOXIDE
- SODIUM LAURYL SULFATE
- TALC
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70771-1521 | 70771-1521-3, 70771-1521-9, 70771-1521-2, 70771-1521-7 |
| 70771-1522 | 70771-1522-3, 70771-1522-9, 70771-1522-2, 70771-1522-7 |
| 70771-1523 | 70771-1523-3, 70771-1523-9, 70771-1523-2, 70771-1523-7 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| 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#
| Application-product | TE code |
|---|---|
| A213065-001 | AB |
| A213065-002 | AB |
| A213065-003 | AB |
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 | 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 | A213065-001 | ERLOTINIB HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2020-04-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A213065-002 | ERLOTINIB HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2020-04-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A213065-003 | ERLOTINIB HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | AB | RS | 2020-04-16 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A213065-001 | ERLOTINIB HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2020-04-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213065-002 | ERLOTINIB HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2020-04-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213065-003 | ERLOTINIB HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | AB | RS | 2020-04-16 | caaa826d4ba7… |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A213065-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A213065-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A213065-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A213065-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213065-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213065-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A213065-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213065-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213065-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213065-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213065-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213065-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213065-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213065-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213065-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213065-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213065-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213065-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213065-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213065-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213065-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213065-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213065-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213065-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213065-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213065-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213065-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213065-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213065-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213065-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213065-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213065-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213065-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A213065-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213065-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213065-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213065-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213065-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213065-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213065-001 | AB | 1 | 301d65b070ca… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Erlotinib | ERLOTINIB | Zydus Lifesciences Limited | daaa1329-3a3f-439c-b13d-b301daa234d4 | 2024-11-28 | 70771-1523-2 70771-1521-2 70771-1523-7 70771-1522-2 70771-1521-3 70771-1522-9 70771-1522-3 70771-1523-3 70771-1521-9 70771-1522-7 70771-1523-9 70771-1521-7 70771-1523 70771-1522 70771-1521 70771152309 70771152109 70771152103 70771152209 70771152303 70771152207 70771152307 70771152302 70771152102 70771152107 70771152203 70771152202 9d253beb-cd1f-45df-9b23-c521269d419f daaa1329-3a3f-439c-b13d-b301daa234d4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.


