Olanzapine
- Product NDC
- 55700-927
- Requested package NDC
- 55700-927-30
- 11-digit product format
- 557000927
- Labeler code
- 55700
- Product ID
- 55700-927_848deabc-5b58-46b5-b638-0e82d19ec72b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA076255
- Marketing category
- ANDA
- Marketing start
- 2021-08-27
- Marketing end
- 0000-00-00
- Substance
- OLANZAPINE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 55700-927 | 55700-927-30 | D | Discontinued by firm | 2026-08-03 |
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.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076255-001 | OLANZAPINE | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2012-04-23 | |
| A076255-002 | OLANZAPINE | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2012-04-23 | |
| A076255-003 | OLANZAPINE | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2012-04-23 | |
| A076255-004 | OLANZAPINE | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2012-04-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076255-001 | AB |
| A076255-002 | AB |
| A076255-003 | AB |
| A076255-004 | 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 | A076255-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2012-04-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076255-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2012-04-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076255-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2012-04-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076255-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2012-04-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076255-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2012-04-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076255-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2012-04-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076255-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2012-04-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076255-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2012-04-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076255-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2012-04-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076255-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2012-04-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076255-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2012-04-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076255-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2012-04-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076255-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2012-04-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076255-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2012-04-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076255-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2012-04-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076255-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2012-04-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076255-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2012-04-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076255-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2012-04-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076255-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2012-04-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076255-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2012-04-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076255-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2012-04-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076255-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2012-04-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076255-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2012-04-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076255-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2012-04-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076255-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2012-04-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076255-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2012-04-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076255-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2012-04-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076255-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2012-04-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076255-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2012-04-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076255-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2012-04-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076255-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2012-04-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076255-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2012-04-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076255-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2012-04-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076255-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2012-04-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076255-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2012-04-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076255-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2012-04-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076255-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2012-04-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076255-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2012-04-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076255-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2012-04-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076255-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2012-04-23 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076255-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076255-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076255-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076255-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076255-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076255-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076255-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076255-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076255-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076255-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076255-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076255-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076255-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076255-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076255-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076255-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076255-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076255-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076255-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076255-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076255-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076255-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076255-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076255-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076255-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076255-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076255-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076255-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076255-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076255-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076255-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076255-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076255-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076255-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076255-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076255-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076255-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076255-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076255-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076255-004 | AB | 1 | d06236e962d9… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55700-927-30 | EA - Each | 55700-927 | 460ee2bb-ae0c-491e-bda6-3000013658ce | 1 | 2021-10-08 |
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. | 2a7300d3-95e3-427e-bf37-55fa654cc90a | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | 076255 ANDA076255 |
| Olanzapine | OLANZAPINE | REMEDYREPACK INC. | 3d69af75-7615-4ec2-b7ef-467b2558c5c8 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | 076255 ANDA076255 |
| Olanzapine | OLANZAPINE | REMEDYREPACK INC. | b513823d-927c-4111-8766-e6c37f84b221 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | 076255 ANDA076255 |
| Olanzapine | OLANZAPINE | REMEDYREPACK INC. | 68de2a51-69b2-4d99-be79-36a95a4bc475 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | 076255 ANDA076255 |
| Olanzapine | OLANZAPINE | Major Pharmaceuticals | 0ecbf540-572e-4ca4-b694-18ca1cd1c194 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | 076255 ANDA076255 |
| Olanzapine | OLANZAPINE | Unit Dose Solutions, Inc. | 55669a10-93f3-cfd6-e063-6294a90aa0e6 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | 076255 ANDA076255 |
| Olanzapine | OLANZAPINE | Unit Dose Solutions, Inc. | 55668be2-62ac-3252-e063-6394a90a40f7 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | 076255 ANDA076255 |
| Olanzapine | OLANZAPINE | Coupler LLC | 53e6b4e9-de26-16c3-e063-6294a90a7764 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 076255 ANDA076255 |
| Olanzapine | OLANZAPINE | Coupler LLC | 52b99337-afa8-a6f9-e063-6294a90a2038 | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | 076255 ANDA076255 |
| Olanzapine | OLANZAPINE | Coupler LLC | 51b64b6d-4676-a637-e063-6394a90a450c | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 076255 ANDA076255 |
| Olanzapine | OLANZAPINE | Dr. Reddy's Laboratories Inc. | d474d5a9-d338-511d-5823-567c0a1bbf4d | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | 076255 ANDA076255 |
| Olanzapine | OLANZAPINE | Cardinal Health 107, LLC | 38a89689-efc2-4931-8f65-868dc0248d6a | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | 076255 ANDA076255 |
| Olanzapine | OLANZAPINE | REMEDYREPACK INC. | dc56c264-d10e-4059-b0d5-2feff16b345d | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | 076255 ANDA076255 |
| Olanzapine | OLANZAPINE | American Health Packaging | 75616c31-8fed-4014-a9f2-4a028eccd586 | 2025-10-20 | Boxed warning, Warnings, Adverse reactions | 076255 ANDA076255 |
| Olanzapine | OLANZAPINE | Preferred Pharmaceuticals Inc. | cfc0f187-d3ff-4bbb-9129-0e94c6eda0ee | 2025-09-05 | Boxed warning, Warnings, Adverse reactions | 076255 ANDA076255 |
| Olanzapine | OLANZAPINE | Preferred Pharmaceuticals Inc. | d349d5b7-5658-46d6-9bba-e6f6361cebb9 | 2025-09-03 | Boxed warning, Warnings, Adverse reactions | 076255 ANDA076255 |
| Olanzapine | OLANZAPINE | PD-Rx Pharmaceuticals, Inc. | 10043041-a632-4e57-bc08-37216dea8546 | 2025-06-23 | Boxed warning, Warnings, Adverse reactions | 076255 ANDA076255 |
| Olanzapine | OLANZAPINE | Bryant Ranch Prepack | 3c9963b1-c498-48a0-a3a1-1eaa6a1028fc | 2025-06-02 | Boxed warning, Warnings, Adverse reactions | 076255 ANDA076255 |
| Olanzapine | OLANZAPINE | Bryant Ranch Prepack | 09e48e71-4dd2-4538-91d7-5b284f6647d8 | 2023-03-29 | Boxed warning, Warnings, Adverse reactions | 076255 ANDA076255 |
| Olanzapine | OLANZAPINE | Dr. Reddy's Laboratories Ltd. | 9a57a63e-f856-aafa-037a-c08f2fea6496 | 2022-10-03 | Boxed warning, Warnings, Adverse reactions | 076255 ANDA076255 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55700-927-30 | 55700092730 | 30 TABLET, FILM COATED in 1 BOTTLE (55700-927-30) | 2021-08-27 | 0000-00-00 | No | No | Current |