Ketorolac Tromethamine
- Product NDC
- 50436-7382
- 11-digit product format
- 504367382
- Labeler code
- 50436
- Product ID
- 50436-7382_c803082a-e64f-495a-ad05-56724bf9fe56
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA074754
- Marketing category
- ANDA
- Marketing start
- 1998-06-17
- Marketing end
- 0000-00-00
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 50436-7382 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 50436-7382 | 50436-7382-1 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 50436-7382 | 50436-7382-2 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074754-001 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 10MG | TABLET / ORAL | AB | RS | 1997-05-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A074754-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A074754-001 | KETOROLAC TROMETHAMINE | 10MG | TABLET / ORAL | AB | RS | 1997-05-16 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A074754-001 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | REMEDYREPACK INC. | f47d4365-40a8-445b-99cd-49edad6a8ffc | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | 074754 ANDA074754 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Sportpharm LLC | 0749f61d-12e6-4280-8f41-bd4df81e7ae6 | 2026-04-05 | Boxed warning, Warnings, Adverse reactions | 074754 ANDA074754 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Northwind Health Company, LLC | d17ed469-677b-4a2e-96a9-5cfd0f50ecd9 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 074754 ANDA074754 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | American Health Packaging | 48244614-53ec-47e6-ad48-50814bdcceb7 | 2025-08-28 | Boxed warning, Warnings, Adverse reactions | 074754 ANDA074754 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | PD-Rx Pharmaceuticals, Inc. | add10ccd-c205-4512-9619-253290fa1152 | 2025-03-12 | Boxed warning, Warnings, Adverse reactions | 074754 ANDA074754 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | A-S Medication Solutions | 9fdba2e6-969f-4624-b08b-a42f99e4eff9 | 2025-02-06 | Boxed warning, Warnings, Adverse reactions | 074754 ANDA074754 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Advanced Rx Pharmacy of Tennessee, LLC | c1717245-cef3-b3d7-e053-2a95a90a1ac5 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 074754 ANDA074754 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Teva Pharmaceuticals USA, Inc. | 688f5dec-a6db-43c6-a1f8-5df99d08d395 | 2024-12-12 | Boxed warning, Warnings, Adverse reactions | 074754 ANDA074754 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | NuCare Pharmaceuticals, Inc. | 415a5393-296f-30e3-e054-00144ff8d46c | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | 074754 ANDA074754 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | NuCare Pharmaceuticals, Inc. | 46dc8f62-e754-50e3-e054-00144ff8d46c | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | 074754 ANDA074754 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Bryant Ranch Prepack | f713500a-20b8-8e20-c4cc-956805170335 | 2023-11-28 | Boxed warning, Warnings, Adverse reactions | 074754 ANDA074754 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Asclemed USA, Inc. | 94c7c57a-fd1e-41ab-bc39-9a538f6011d1 | 2023-09-06 | Boxed warning, Warnings, Adverse reactions | 074754 ANDA074754 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Proficient Rx LP | f5170993-81a9-4eb7-95ac-60697a5ee1d7 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 074754 ANDA074754 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50436-7382-2 | EA - Each | 50436-7382 | 18e05d81-b652-487c-8959-a0188bcfabdc | 1 | 2014-12-01 |