ZYPREXA
- Product NDC
- 61269-640
- 11-digit product format
- 612690640
- Labeler code
- 61269
- Product ID
- 61269-640_40d4ed67-c51d-40d0-8a32-ecfdbf069f9a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- H2-Pharma LLC
- Application
- NDA021253
- Marketing category
- NDA
- Marketing start
- 2004-04-01
- Substance
- OLANZAPINE
- Active strength
- 10 mg/2mL
- 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 |
|---|---|---|---|---|---|---|---|
| N021253-001 | ZYPREXA | OLANZAPINE | 10MG/VIAL | POWDER / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021253-001 | AP |
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 | N021253-001 | ZYPREXA | 10MG/VIAL | POWDER / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021253-001 | ZYPREXA | 10MG/VIAL | INJECTABLE / INTRAMUSCULAR | AP | RLD, RS | 2004-03-29 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021253-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021253-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021253-001 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021253-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021253-001 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021253-001 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021253-001 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021253-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021253-001 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021253-001 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021253-001 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021253-001 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021253-001 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021253-001 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021253-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021253-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021253-001 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021253-001 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021253-001 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021253-001 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021253-001 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021253-001 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021253-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021253-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021253-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021253-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021253-001 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021253-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N021253-001 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N021253-001 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021253-001 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021253-001 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021253-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021253-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N021253-001 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N021253-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021253-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N021253-001 | AP | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N021253-001 | AP | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021253-001 | AP | 1 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ZYPREXA
- Brand name suffix
- Intramuscular
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OLANZAPINE | 10 mg/2mL |
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 |
|---|---|---|---|---|---|---|
| 61269-640-20 | ZYPREXA Intramuscular | 1 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 1 | 68 | |
| 61269-640-20 | ZYPREXA Intramuscular | 2 mL in 1 VIAL | INJECTION, POWDER, FOR SOLUTION | 2 | 68 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61269-640-20 | EA - Each | 61269-640 | 35650d19-df62-40a6-99fd-3b10651a83cf | 1 | 2026-01-08 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61269-640 | ZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [H2-PHARMA LLC] | 66 | Current NDC, 2 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 | 021253 NDA021253 61269-640 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 61269-640-20 | 61269064020 | 1 VIAL in 1 CARTON (61269-640-20) / 2 mL in 1 VIAL | 1 vial | 2004-04-01 | No | No | Current |