Olanzapine
- Product NDC
- 70518-2698
- Requested package NDC
- 70518-2698-0
- 11-digit product format
- 705182698
- Labeler code
- 70518
- Product ID
- 70518-2698_f0d0df2e-dac5-1427-e053-2995a90adb2e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA202862
- Marketing category
- ANDA
- Marketing start
- 2020-04-17
- Marketing end
- 0000-00-00
- Substance
- OLANZAPINE
- Active strength
- 5 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 | 70518-2698 | 70518-2698-0 | D | Discontinued by firm | 2026-08-17 |
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… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202862-001 | OLANZAPINE | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2014-08-15 | |
| A202862-002 | OLANZAPINE | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2014-08-15 | |
| A202862-003 | OLANZAPINE | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2014-08-15 | |
| A202862-004 | OLANZAPINE | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2014-08-15 | |
| A202862-005 | OLANZAPINE | OLANZAPINE | 15MG | TABLET / ORAL | AB | 2014-08-15 | |
| A202862-006 | OLANZAPINE | OLANZAPINE | 20MG | TABLET / ORAL | AB | 2014-08-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202862-001 | AB |
| A202862-002 | AB |
| A202862-003 | AB |
| A202862-004 | AB |
| A202862-005 | AB |
| A202862-006 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A202862-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2014-08-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202862-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2014-08-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202862-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2014-08-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202862-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2014-08-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202862-005 | OLANZAPINE | 15MG | TABLET / ORAL | AB | 2014-08-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202862-006 | OLANZAPINE | 20MG | TABLET / ORAL | AB | 2014-08-15 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202862-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2014-08-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202862-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2014-08-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202862-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2014-08-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202862-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2014-08-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202862-005 | OLANZAPINE | 15MG | TABLET / ORAL | AB | 2014-08-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202862-006 | OLANZAPINE | 20MG | TABLET / ORAL | AB | 2014-08-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202862-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2014-08-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202862-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2014-08-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202862-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2014-08-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202862-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2014-08-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202862-005 | OLANZAPINE | 15MG | TABLET / ORAL | AB | 2014-08-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202862-006 | OLANZAPINE | 20MG | TABLET / ORAL | AB | 2014-08-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202862-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2014-08-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202862-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2014-08-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202862-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2014-08-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202862-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2014-08-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202862-005 | OLANZAPINE | 15MG | TABLET / ORAL | AB | 2014-08-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202862-006 | OLANZAPINE | 20MG | TABLET / ORAL | AB | 2014-08-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202862-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2014-08-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202862-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2014-08-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202862-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2014-08-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202862-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2014-08-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202862-005 | OLANZAPINE | 15MG | TABLET / ORAL | AB | 2014-08-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202862-006 | OLANZAPINE | 20MG | TABLET / ORAL | AB | 2014-08-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202862-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2014-08-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202862-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2014-08-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202862-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2014-08-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202862-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2014-08-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202862-005 | OLANZAPINE | 15MG | TABLET / ORAL | AB | 2014-08-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202862-006 | OLANZAPINE | 20MG | TABLET / ORAL | AB | 2014-08-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202862-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2014-08-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202862-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2014-08-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202862-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2014-08-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202862-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2014-08-15 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A202862-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202862-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202862-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202862-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202862-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202862-006 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A202862-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202862-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202862-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202862-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202862-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202862-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202862-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202862-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202862-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202862-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202862-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202862-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202862-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202862-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202862-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202862-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202862-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202862-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202862-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202862-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202862-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202862-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202862-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202862-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202862-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202862-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202862-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202862-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202862-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202862-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202862-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202862-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202862-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202862-004 | AB | 1 | 03ed91905a0d… |
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 | Preferred Pharmaceuticals Inc. | 5bded04a-d848-4ac6-b7c3-ff9b9fef3d29 | 2026-08-06 | Boxed warning, Warnings, Adverse reactions | 202862 ANDA202862 |
| Olanzapine | OLANZAPINE | REMEDYREPACK INC. | 9eb6b0d1-b301-4847-88f5-f8613d550ecc | 2026-07-22 | Boxed warning, Warnings, Adverse reactions | 202862 ANDA202862 |
| Olanzapine | OLANZAPINE | PD-Rx Pharmaceuticals, Inc. | b6f0b2e2-3cbd-4564-8b3e-f811589af275 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | 202862 ANDA202862 |
| Olanzapine | OLANZAPINE | REMEDYREPACK INC. | 8e5ef52d-315b-4055-9e52-403e6f896f24 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | 202862 ANDA202862 |
| Olanzapine | OLANZAPINE | Redpharm Drug | 54adae9e-6781-6a77-e063-6394a90ab5c8 | 2026-06-20 | Boxed warning, Warnings, Adverse reactions | 202862 ANDA202862 |
| Olanzapine | OLANZAPINE | Coupler LLC | 549dc142-adcd-99ed-e063-6294a90a37fa | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | 202862 ANDA202862 |
| Olanzapine | OLANZAPINE | Coupler LLC | 52bdaaaf-ab54-99d1-e063-6394a90a521f | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | 202862 ANDA202862 |
| Olanzapine | OLANZAPINE | Coupler LLC | 518a9400-edb8-6403-e063-6294a90a065d | 2026-05-11 | Boxed warning, Warnings, Adverse reactions | 202862 ANDA202862 |
| Olanzapine | OLANZAPINE | REMEDYREPACK INC. | 76a6ff21-7157-4213-8073-35837a3ac07e | 2026-03-26 | Boxed warning, Warnings, Adverse reactions | 202862 ANDA202862 |
| Olanzapine | OLANZAPINE | Macleods Pharmaceuticals Limited | 8e095987-bdea-42f2-9550-c7155cf07d30 | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 202862 ANDA202862 |
| Olanzapine | OLANZAPINE | REMEDYREPACK INC. | 88edb3fc-fcb6-4483-859d-f830b077aca2 | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | 202862 ANDA202862 |
| Olanzapine | OLANZAPINE | Bryant Ranch Prepack | f6fd7ceb-1457-4c3e-9d30-4f658f39d37d | 2025-05-21 | Boxed warning, Warnings, Adverse reactions | 202862 ANDA202862 |
| Olanzapine | OLANZAPINE | Bryant Ranch Prepack | c47f90fc-49fe-4f60-9da8-1365a1650dd9 | 2025-05-15 | Boxed warning, Warnings, Adverse reactions | 202862 ANDA202862 |
| Olanzapine | OLANZAPINE | Bryant Ranch Prepack | dcf8fcbf-636c-41ad-8084-c65ac2f117cc | 2025-05-12 | Boxed warning, Warnings, Adverse reactions | 202862 ANDA202862 |
| Olanzapine | OLANZAPINE | Bryant Ranch Prepack | 8586e828-34e7-4eb4-a933-6c688927478f | 2025-04-23 | Boxed warning, Warnings, Adverse reactions | 202862 ANDA202862 |
| Olanzapine | OLANZAPINE | NCS HealthCare of KY, LLC dba Vangard Labs | 87b7fb23-c9b7-433f-bd17-cd3e91714c27 | 2025-03-03 | Boxed warning, Warnings, Adverse reactions | 202862 ANDA202862 |
| Olanzapine | OLANZAPINE | Direct_Rx | fcec190f-b865-c5d3-e053-6394a90a7e45 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 202862 ANDA202862 |
| Olanzapine | OLANZAPINE | Direct_Rx | 22528ae1-e36f-48e1-e063-6294a90a3dd2 | 2024-09-17 | Boxed warning, Warnings, Adverse reactions | 202862 ANDA202862 |
| Olanzapine | OLANZAPINE | NorthStar RxLLC | ea3259d5-36ee-4ac9-b849-9625626e2187 | 2024-07-03 | Boxed warning, Warnings, Adverse reactions | 202862 ANDA202862 |
| Olanzapine | OLANZAPINE | Proficient Rx LP | ce66d545-015b-41d5-80c3-964d78e36bfd | 2023-02-01 | Boxed warning, Warnings, Adverse reactions | 202862 ANDA202862 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70518-2698-0 | 70518269800 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2698-0) | 2020-04-17 | 0000-00-00 | No | No | Current |