Zyprexa
- Product NDC
- 61269-630
- 11-digit product format
- 612690630
- Labeler code
- 61269
- Product ID
- 61269-630_40d4ed67-c51d-40d0-8a32-ecfdbf069f9a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- H2-Pharma LLC
- Application
- NDA020592
- Marketing category
- NDA
- Marketing start
- 1997-06-23
- Substance
- OLANZAPINE
- Active strength
- 2.5 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 |
|---|---|---|---|---|---|---|---|
| N020592-001 | ZYPREXA | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 |
| N020592-002 | ZYPREXA | OLANZAPINE | 5MG | TABLET / ORAL | AB | RLD, RS | 1996-09-30 |
| N020592-003 | ZYPREXA | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 |
| N020592-004 | ZYPREXA | OLANZAPINE | 10MG | TABLET / ORAL | AB | RLD | 1996-09-30 |
| N020592-005 | ZYPREXA | OLANZAPINE | 15MG | TABLET / ORAL | AB | RLD | 1997-09-09 |
| N020592-006 | ZYPREXA | OLANZAPINE | 20MG | TABLET / ORAL | AB | RLD | 1997-09-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020592-001 | AB |
| N020592-002 | AB |
| N020592-003 | AB |
| N020592-004 | AB |
| N020592-005 | AB |
| N020592-006 | 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 | N020592-001 | ZYPREXA | 2.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020592-002 | ZYPREXA | 5MG | TABLET / ORAL | AB | RLD, RS | 1996-09-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020592-003 | ZYPREXA | 7.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020592-004 | ZYPREXA | 10MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020592-005 | ZYPREXA | 15MG | TABLET / ORAL | AB | RLD | 1997-09-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020592-006 | ZYPREXA | 20MG | TABLET / ORAL | AB | RLD | 1997-09-09 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020592-001 | ZYPREXA | 2.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020592-002 | ZYPREXA | 5MG | TABLET / ORAL | AB | RLD, RS | 1996-09-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020592-003 | ZYPREXA | 7.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020592-004 | ZYPREXA | 10MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020592-005 | ZYPREXA | 15MG | TABLET / ORAL | AB | RLD | 1997-09-09 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020592-006 | ZYPREXA | 20MG | TABLET / ORAL | AB | RLD | 1997-09-09 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020592-001 | ZYPREXA | 2.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020592-002 | ZYPREXA | 5MG | TABLET / ORAL | AB | RLD, RS | 1996-09-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020592-003 | ZYPREXA | 7.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020592-004 | ZYPREXA | 10MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020592-005 | ZYPREXA | 15MG | TABLET / ORAL | AB | RLD | 1997-09-09 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020592-006 | ZYPREXA | 20MG | TABLET / ORAL | AB | RLD | 1997-09-09 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020592-001 | ZYPREXA | 2.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020592-002 | ZYPREXA | 5MG | TABLET / ORAL | AB | RLD, RS | 1996-09-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020592-003 | ZYPREXA | 7.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020592-004 | ZYPREXA | 10MG | TABLET / ORAL | AB | RLD | 1996-09-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020592-005 | ZYPREXA | 15MG | TABLET / ORAL | AB | RLD | 1997-09-09 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020592-006 | ZYPREXA | 20MG | TABLET / ORAL | AB | RLD | 1997-09-09 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020592-001 | ZYPREXA | 2.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020592-002 | ZYPREXA | 5MG | TABLET / ORAL | AB | RLD, RS | 1996-09-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020592-003 | ZYPREXA | 7.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020592-004 | ZYPREXA | 10MG | TABLET / ORAL | AB | RLD | 1996-09-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020592-005 | ZYPREXA | 15MG | TABLET / ORAL | AB | RLD | 1997-09-09 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020592-006 | ZYPREXA | 20MG | TABLET / ORAL | AB | RLD | 1997-09-09 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020592-001 | ZYPREXA | 2.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020592-002 | ZYPREXA | 5MG | TABLET / ORAL | AB | RLD, RS | 1996-09-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020592-003 | ZYPREXA | 7.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020592-004 | ZYPREXA | 10MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020592-005 | ZYPREXA | 15MG | TABLET / ORAL | AB | RLD | 1997-09-09 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020592-006 | ZYPREXA | 20MG | TABLET / ORAL | AB | RLD | 1997-09-09 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020592-001 | ZYPREXA | 2.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020592-002 | ZYPREXA | 5MG | TABLET / ORAL | AB | RLD, RS | 1996-09-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020592-003 | ZYPREXA | 7.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020592-004 | ZYPREXA | 10MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 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 | N020592-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020592-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020592-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020592-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020592-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020592-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020592-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020592-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020592-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020592-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020592-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020592-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020592-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020592-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020592-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020592-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020592-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020592-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020592-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020592-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020592-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020592-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020592-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020592-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020592-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020592-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020592-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020592-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020592-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020592-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020592-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020592-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020592-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020592-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020592-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020592-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020592-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020592-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020592-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020592-004 | AB | 1 | 2680178bc6a6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zyprexa
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OLANZAPINE | 2.5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| N7U69T4SZR | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 153046 | Internal RxNorm lookup |
| 153047 | Internal RxNorm lookup |
| 153048 | Internal RxNorm lookup |
| 200034 | Internal RxNorm lookup |
| 212405 | Internal RxNorm lookup |
| 261337 | Internal RxNorm lookup |
| 283639 | Internal RxNorm lookup |
| 284514 | Internal RxNorm lookup |
| 312076 | Internal RxNorm lookup |
| 312077 | Internal RxNorm lookup |
| 312078 | Internal RxNorm lookup |
| 312079 | Internal RxNorm lookup |
| 314154 | Internal RxNorm lookup |
| 314155 | Internal RxNorm lookup |
| 351107 | Internal RxNorm lookup |
| 351108 | Internal RxNorm lookup |
| 485968 | Internal RxNorm lookup |
| 545353 | Internal RxNorm lookup |
| 754503 | Internal RxNorm lookup |
| 754504 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b418946a-1ab4-4d89-a012-d94fc361a3c4 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| 61269-630-30 | Zyprexa | 30 in 1 BOTTLE | TABLET | 30 | 68 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61269-630-30 | EA - Each | 61269-630 | 3feb8ac9-07f6-431e-a715-cd89aa7129af | 1 | 2025-06-13 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61269-630 | ZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [H2-PHARMA LLC] | 66 | Current NDC, 1 package rows | 20250207_b418946a-1ab4-4d89-a012-d94fc361a3c4.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 | 020592 NDA020592 61269-630 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 61269-630-30 | 61269063030 | 30 TABLET in 1 BOTTLE (61269-630-30) | 30 tablet | 1997-06-23 | No | No | Current |