CELECOXIB
- Product NDC
- 70934-213
- Requested package NDC
- 70934-213-90
- 11-digit product format
- 709340213
- Labeler code
- 70934
- Product ID
- 70934-213_f1623deb-4a79-3e68-e053-2a95a90aec16
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Celecoxib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Denton Pharma, Inc. DBA Northwind Pharmaceuticals
- Application
- ANDA204776
- Marketing category
- ANDA
- Marketing start
- 2018-12-27
- Marketing end
- 2023-04-30
- Substance
- CELECOXIB
- Active strength
- 200 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 | 70934-213 | 70934-213-90 | D | Discontinued by firm | 2026-08-07 |
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… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204776-001 | CELECOXIB | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-04-30 | |
| A204776-002 | CELECOXIB | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2018-04-30 | |
| A204776-003 | CELECOXIB | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2018-04-30 | |
| A204776-004 | CELECOXIB | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2018-04-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204776-001 | AB |
| A204776-002 | AB |
| A204776-003 | AB |
| A204776-004 | 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 | A204776-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-04-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204776-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2018-04-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204776-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2018-04-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204776-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2018-04-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204776-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-04-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204776-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2018-04-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204776-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2018-04-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204776-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2018-04-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204776-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-04-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204776-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2018-04-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204776-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2018-04-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204776-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2018-04-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204776-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-04-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204776-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2018-04-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204776-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2018-04-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204776-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2018-04-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204776-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-04-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204776-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2018-04-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204776-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2018-04-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204776-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2018-04-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204776-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-04-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204776-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2018-04-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204776-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2018-04-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204776-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2018-04-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204776-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-04-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204776-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2018-04-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204776-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2018-04-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204776-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2018-04-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204776-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-04-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204776-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2018-04-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204776-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2018-04-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204776-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2018-04-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204776-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-04-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204776-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2018-04-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204776-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2018-04-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204776-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2018-04-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204776-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-04-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204776-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2018-04-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204776-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2018-04-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204776-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2018-04-30 | 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 | A204776-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204776-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204776-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204776-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204776-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204776-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204776-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204776-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204776-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204776-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204776-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204776-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204776-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204776-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204776-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204776-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204776-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204776-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204776-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204776-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204776-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204776-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204776-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204776-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204776-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204776-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204776-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204776-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204776-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204776-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204776-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204776-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204776-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204776-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204776-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204776-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A204776-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204776-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204776-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204776-004 | AB | 1 | d06236e962d9… |
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 |
|---|---|---|---|---|---|---|
| CELECOXIB | CELECOXIB | American Health Packaging | 4af52ae3-6b9d-4bc9-ad6b-c983e4c9dcc7 | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | 204776 ANDA204776 |
| CELECOXIB | CELECOXIB | Northwind Health Company, LLC | dabfb290-0a7f-3429-e053-2a95a90ae04c | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 204776 ANDA204776 |
| CELECOXIB | CELECOXIB | Northwind Health Company, LLC | dac05189-4acf-d6bb-e053-2a95a90a46a9 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 204776 ANDA204776 |
| CELECOXIB | CELECOXIB | Micro Labs Limited | 408b30d6-f5c2-4239-b993-d8f77a8e160b | 2025-05-13 | Boxed warning, Warnings, Adverse reactions | 204776 ANDA204776 |
| CELECOXIB | CELECOXIB | Bryant Ranch Prepack | 550c828b-8c88-4c47-a7b8-a436aed46dc7 | 2025-01-30 | Boxed warning, Warnings, Adverse reactions | 204776 ANDA204776 |
| CELECOXIB | CELECOXIB | Bryant Ranch Prepack | deeecba5-7a76-444b-a891-b00b1fb16d51 | 2025-01-29 | Boxed warning, Warnings, Adverse reactions | 204776 ANDA204776 |
| Celecoxib | CELECOXIB | Advanced Rx of Tennessee, LLC | af9da1f2-717b-32b6-e053-2995a90ae585 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 204776 ANDA204776 |
| CELECOXIB | CELECOXIB | Proficient Rx LP | 1071fcb5-0e9f-4e30-8fb4-df76fd876fe8 | 2024-09-01 | Boxed warning, Warnings, Adverse reactions | 204776 ANDA204776 |
| CELECOXIB | CELECOXIB | Bryant Ranch Prepack | 627abea5-e39a-4e4f-b1ab-4842ed8112e9 | 2024-08-15 | Boxed warning, Warnings, Adverse reactions | 204776 ANDA204776 |
| CELECOXIB | CELECOXIB | A-S Medication Solutions | 00e67d5e-df6f-4dfd-8c2d-a001c8a99af0 | 2023-08-24 | Boxed warning, Warnings, Adverse reactions | 204776 ANDA204776 |
| CELECOXIB | CELECOXIB | A-S Medication Solutions | c7a183dc-f4d5-483f-964c-f2745a3640ad | 2023-02-28 | Boxed warning, Warnings, Adverse reactions | 204776 ANDA204776 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70934-213-90 | 70934021390 | 90 CAPSULE in 1 BOTTLE, PLASTIC (70934-213-90) | 90 capsule | 2019-06-05 | 2023-04-30 | No | No | Current |