ZYPREXA
- Product NDC
- 0002-4454
- Requested package NDC
- 0002-4454-85
- 11-digit product format
- 000024454
- Labeler code
- 0002
- Product ID
- 0002-4454_8008d181-4679-4320-a624-0072056c40c7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Eli Lilly and Company
- Application
- NDA021086
- Marketing category
- NDA
- Marketing start
- 2000-06-01
- 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 | 0002-4454 | 0002-4454-85 | D | Discontinued by firm | 2026-08-07 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021086-001 | ZYPREXA ZYDIS | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD, RS | 2000-04-06 |
| N021086-002 | ZYPREXA ZYDIS | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 |
| N021086-003 | ZYPREXA ZYDIS | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 |
| N021086-004 | ZYPREXA ZYDIS | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021086-001 | AB |
| N021086-002 | AB |
| N021086-003 | AB |
| N021086-004 | 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 | N021086-001 | ZYPREXA ZYDIS | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD, RS | 2000-04-06 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021086-002 | ZYPREXA ZYDIS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021086-003 | ZYPREXA ZYDIS | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021086-004 | ZYPREXA ZYDIS | 20MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021086-001 | ZYPREXA ZYDIS | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD, RS | 2000-04-06 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021086-002 | ZYPREXA ZYDIS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021086-003 | ZYPREXA ZYDIS | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021086-004 | ZYPREXA ZYDIS | 20MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021086-001 | ZYPREXA ZYDIS | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD, RS | 2000-04-06 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021086-002 | ZYPREXA ZYDIS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021086-003 | ZYPREXA ZYDIS | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021086-004 | ZYPREXA ZYDIS | 20MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021086-001 | ZYPREXA ZYDIS | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD, RS | 2000-04-06 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021086-002 | ZYPREXA ZYDIS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021086-003 | ZYPREXA ZYDIS | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021086-004 | ZYPREXA ZYDIS | 20MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021086-001 | ZYPREXA ZYDIS | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD, RS | 2000-04-06 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021086-002 | ZYPREXA ZYDIS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021086-003 | ZYPREXA ZYDIS | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021086-004 | ZYPREXA ZYDIS | 20MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021086-001 | ZYPREXA ZYDIS | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD, RS | 2000-04-06 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021086-002 | ZYPREXA ZYDIS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021086-003 | ZYPREXA ZYDIS | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021086-004 | ZYPREXA ZYDIS | 20MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021086-001 | ZYPREXA ZYDIS | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD, RS | 2000-04-06 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021086-002 | ZYPREXA ZYDIS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021086-003 | ZYPREXA ZYDIS | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021086-004 | ZYPREXA ZYDIS | 20MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021086-001 | ZYPREXA ZYDIS | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD, RS | 2000-04-06 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021086-002 | ZYPREXA ZYDIS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021086-003 | ZYPREXA ZYDIS | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021086-004 | ZYPREXA ZYDIS | 20MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021086-001 | ZYPREXA ZYDIS | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD, RS | 2000-04-06 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021086-002 | ZYPREXA ZYDIS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021086-003 | ZYPREXA ZYDIS | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021086-004 | ZYPREXA ZYDIS | 20MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021086-001 | ZYPREXA ZYDIS | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD, RS | 2000-04-06 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021086-002 | ZYPREXA ZYDIS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021086-003 | ZYPREXA ZYDIS | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021086-004 | ZYPREXA ZYDIS | 20MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2000-04-06 | 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 | N021086-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021086-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021086-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021086-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021086-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021086-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021086-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021086-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021086-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021086-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021086-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021086-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021086-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021086-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021086-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021086-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021086-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021086-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021086-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021086-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021086-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021086-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021086-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021086-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021086-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021086-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021086-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021086-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021086-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021086-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021086-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021086-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021086-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021086-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021086-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021086-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021086-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021086-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021086-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021086-004 | AB | 1 | d06236e962d9… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 42e9462d-db65-453b-8069-8fb2df9182e8 | Product name | 1 | 20211216 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 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 |
|---|---|---|---|---|---|---|
| 0002-4454-01 | ZYPREXA Zydis | 1 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 1 | 67 | |
| 0002-4454-01 | ZYPREXA Zydis | 1 in 1 DOSE PACK | TABLET, ORALLY DISINTEGRATING | 1 | 67 | |
| 0002-4454-85 | ZYPREXA Zydis | 30 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 30 | 67 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0002-4454-01 | EA - Each | 0002-4454 | 7e221558-7584-4b8b-b359-bbce11fe7e20 | 1 | 2012-07-24 |
| 0002-4454-85 | EA - Each | 0002-4454 | 9879037d-1deb-4639-8596-ead22339987d | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0002-4454 | ZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ] | 66 | Legacy NDC, 3 package rows | 20250110_d5051fbc-846b-4946-82df-341fb1216341.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Zyprexa | OLANZAPINE | H2-Pharma LLC | b418946a-1ab4-4d89-a012-d94fc361a3c4 | 2026-02-11 | Boxed warning, Warnings, Adverse reactions | 021086 NDA021086 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0002-4454-85 | 00002445485 | 30 DOSE PACK in 1 CARTON (0002-4454-85) > 1 BLISTER PACK in 1 DOSE PACK (0002-4454-01) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 30 dose pack | 2000-06-01 | 0000-00-00 | No | No | Current |