Olanzapine
- Product NDC
- 60429-624
- 11-digit product format
- 604290624
- Labeler code
- 60429
- Product ID
- 60429-624_5023a1ed-b0d6-44d2-e063-6394a90ae2c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Golden State Medical Supply, Inc.
- Application
- ANDA090798
- Marketing category
- ANDA
- Marketing start
- 2012-04-23
- Substance
- OLANZAPINE
- Active strength
- 15 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090798-001 | OLANZAPINE | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2012-04-23 | |
| A090798-002 | OLANZAPINE | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2012-04-23 | |
| A090798-003 | OLANZAPINE | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2012-04-23 | |
| A090798-004 | OLANZAPINE | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2012-04-23 | |
| A090798-005 | OLANZAPINE | OLANZAPINE | 15MG | TABLET / ORAL | AB | 2012-04-23 | |
| A090798-006 | OLANZAPINE | OLANZAPINE | 20MG | TABLET / ORAL | AB | 2012-04-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090798-001 | AB |
| A090798-002 | AB |
| A090798-003 | AB |
| A090798-004 | AB |
| A090798-005 | AB |
| A090798-006 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A090798-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2012-04-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090798-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2012-04-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090798-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2012-04-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090798-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2012-04-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090798-005 | OLANZAPINE | 15MG | TABLET / ORAL | AB | 2012-04-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090798-006 | OLANZAPINE | 20MG | TABLET / ORAL | AB | 2012-04-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090798-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2012-04-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090798-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2012-04-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090798-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2012-04-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090798-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2012-04-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090798-005 | OLANZAPINE | 15MG | TABLET / ORAL | AB | 2012-04-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090798-006 | OLANZAPINE | 20MG | TABLET / ORAL | AB | 2012-04-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090798-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2012-04-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090798-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2012-04-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090798-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2012-04-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090798-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2012-04-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090798-005 | OLANZAPINE | 15MG | TABLET / ORAL | AB | 2012-04-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090798-006 | OLANZAPINE | 20MG | TABLET / ORAL | AB | 2012-04-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090798-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2012-04-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090798-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2012-04-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090798-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2012-04-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090798-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2012-04-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090798-005 | OLANZAPINE | 15MG | TABLET / ORAL | AB | 2012-04-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090798-006 | OLANZAPINE | 20MG | TABLET / ORAL | AB | 2012-04-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090798-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2012-04-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090798-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2012-04-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090798-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2012-04-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090798-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2012-04-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090798-005 | OLANZAPINE | 15MG | TABLET / ORAL | AB | 2012-04-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090798-006 | OLANZAPINE | 20MG | TABLET / ORAL | AB | 2012-04-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090798-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2012-04-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090798-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2012-04-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090798-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2012-04-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090798-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2012-04-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090798-005 | OLANZAPINE | 15MG | TABLET / ORAL | AB | 2012-04-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090798-006 | OLANZAPINE | 20MG | TABLET / ORAL | AB | 2012-04-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090798-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2012-04-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090798-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2012-04-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090798-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2012-04-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090798-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2012-04-23 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A090798-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090798-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090798-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090798-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090798-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090798-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090798-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090798-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090798-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090798-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090798-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090798-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090798-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090798-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090798-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090798-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090798-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090798-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090798-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090798-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090798-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090798-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090798-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090798-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090798-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090798-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090798-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090798-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090798-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090798-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090798-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090798-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090798-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090798-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090798-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090798-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090798-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090798-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090798-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090798-004 | AB | 1 | 2680178bc6a6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Olanzapine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OLANZAPINE | 15 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| N7U69T4SZR | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a1dfb4e7-4143-4422-b7a7-292e4fd75044 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 42e9462d-db65-453b-8069-8fb2df9182e8 | Product name | 1 | 20211216 |
| 12d02c27-e8da-47f1-b815-ccca982731ef | Product name | 9 | 20170802 |
| 877783eb-030c-6e3f-0979-804cf94d8856 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60429-624-10 | Olanzapine | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 12 | |
| 60429-624-30 | Olanzapine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60429-624-10 | EA - Each | 60429-624 | 04910e4d-d9e0-41d9-af09-cf59f2056c14 | 1 | 2019-12-10 |
| 60429-624-30 | EA - Each | 60429-624 | a40b9d06-916f-43da-82a8-465baf053318 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Olanzapine | OLANZAPINE | REMEDYREPACK INC. | e830f488-c689-40f6-9351-f9c7454ff1ea | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | 090798 ANDA090798 |
| Olanzapine | OLANZAPINE | REMEDYREPACK INC. | 032e589c-47b1-4eb1-9466-8160297b81e9 | 2026-06-03 | Boxed warning, Warnings, Adverse reactions | 090798 ANDA090798 |
| Olanzapine | OLANZAPINE | Golden State Medical Supply, Inc. | a1dfb4e7-4143-4422-b7a7-292e4fd75044 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | 090798 ANDA090798 60429-624 |
| Olanzapine | OLANZAPINE | Apotex Corp. | 3347d1c8-04c9-5ce1-8cda-b38e0412b709 | 2025-11-18 | Boxed warning, Warnings, Adverse reactions | 090798 ANDA090798 |
| Olanzapine | OLANZAPINE | Bryant Ranch Prepack | 1866a03c-eac9-44a1-8f33-7dc6e8a8c06a | 2025-06-05 | Boxed warning, Warnings, Adverse reactions | 090798 ANDA090798 |
| Olanzapine | OLANZAPINE | Proficient Rx LP | 024e8e9b-a4fc-4882-b080-c070467166a6 | 2024-01-01 | Boxed warning, Warnings, Adverse reactions | 090798 ANDA090798 |
| Olanzapine | OLANZAPINE | Proficient Rx LP | e40d54bf-7334-4418-8a87-ff85941adec1 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | 090798 ANDA090798 |
| Olanzapine | OLANZAPINE | Aphena Pharma Solutions - Tennessee, LLC | b6ec5610-b4a6-4646-954a-0fe8b1d3e143 | 2020-05-05 | Boxed warning, Warnings, Adverse reactions | 090798 ANDA090798 |
| Olanzapine | OLANZAPINE | Proficient Rx LP | 7772a4c2-1fb1-412b-9e3b-ef3d693517a2 | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | 090798 ANDA090798 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314154 | OLANZapine 10 MG Oral Tablet | PSN | a1dfb4e7-4143-4422-b7a7-292e4fd75044 | 12 |
| 312077 | OLANZapine 15 MG Oral Tablet | PSN | a1dfb4e7-4143-4422-b7a7-292e4fd75044 | 12 |
| 200034 | OLANZapine 2.5 MG Oral Tablet | PSN | a1dfb4e7-4143-4422-b7a7-292e4fd75044 | 12 |
| 283639 | OLANZapine 20 MG Oral Tablet | PSN | a1dfb4e7-4143-4422-b7a7-292e4fd75044 | 12 |
| 312078 | OLANZapine 5 MG Oral Tablet | PSN | a1dfb4e7-4143-4422-b7a7-292e4fd75044 | 12 |
| 312079 | OLANZapine 7.5 MG Oral Tablet | PSN | a1dfb4e7-4143-4422-b7a7-292e4fd75044 | 12 |
| 314154 | olanzapine 10 MG Oral Tablet | SCD | a1dfb4e7-4143-4422-b7a7-292e4fd75044 | 12 |
| 312077 | olanzapine 15 MG Oral Tablet | SCD | a1dfb4e7-4143-4422-b7a7-292e4fd75044 | 12 |
| 200034 | olanzapine 2.5 MG Oral Tablet | SCD | a1dfb4e7-4143-4422-b7a7-292e4fd75044 | 12 |
| 283639 | olanzapine 20 MG Oral Tablet | SCD | a1dfb4e7-4143-4422-b7a7-292e4fd75044 | 12 |
| 312078 | olanzapine 5 MG Oral Tablet | SCD | a1dfb4e7-4143-4422-b7a7-292e4fd75044 | 12 |
| 312079 | olanzapine 7.5 MG Oral Tablet | SCD | a1dfb4e7-4143-4422-b7a7-292e4fd75044 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 60429-624-10 | 60429062410 | 1000 TABLET, FILM COATED in 1 BOTTLE (60429-624-10) | 2019-10-16 | 0000-00-00 | No | No | Current |
| 60429-624-30 | 60429062430 | 30 TABLET, FILM COATED in 1 BOTTLE (60429-624-30) | 2019-10-16 | 0000-00-00 | No | No | Current |