Ketorolac Tromethamine
- Product NDC
- 50090-0601
- 11-digit product format
- 500900601
- Labeler code
- 50090
- Product ID
- 50090-0601_ceb5f90c-3ac7-4753-afac-c001f6ad150e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA074754
- Marketing category
- ANDA
- Marketing start
- 1998-06-17
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ketorolac Tromethamine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETOROLAC TROMETHAMINE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4EVE5946BQ |
| Rxcui | 834022 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-0601-0 | 2023-02-07 | C162847 | 48780-1 | f386c649-b6d1-0266-e053-dadaa90a7c1a | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 50090-0601-2 | 2023-02-07 | C162847 | 48780-1 | f386c649-b6d1-0266-e053-dadaa90a7c1a | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 50090-0601-3 | 2023-02-07 | C162847 | 48780-1 | f386c649-b6d1-0266-e053-dadaa90a7c1a | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 50090-0601-5 | 2023-02-07 | C162847 | 48780-1 | f386c649-b6d1-0266-e053-dadaa90a7c1a | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 50090-0601-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-b6d1-0266-e053-dadaa90a7c1a | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 50090-0601-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-b6d1-0266-e053-dadaa90a7c1a | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 50090-0601-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-b6d1-0266-e053-dadaa90a7c1a | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 50090-0601-5 | 2023-01-30 | C162847 | 48780-1 | f386c649-b6d1-0266-e053-dadaa90a7c1a | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-0601-0 | Ketorolac Tromethamine | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 17 |
| 50090-0601-2 | Ketorolac Tromethamine | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 17 |
| 50090-0601-3 | Ketorolac Tromethamine | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 17 |
| 50090-0601-5 | Ketorolac Tromethamine | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-0601 | KETOROLAC TROMETHAMINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 17 | Current NDC, Legacy NDC, 4 package rows | 20250209_9fdba2e6-969f-4624-b08b-a42f99e4eff9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-0601-0 | 50090060100 | 20 TABLET, FILM COATED in 1 BOTTLE (50090-0601-0) | 2014-11-28 | 0000-00-00 | No | No | Current |
| 50090-0601-2 | 50090060102 | 15 TABLET, FILM COATED in 1 BOTTLE (50090-0601-2) | 2014-11-28 | 0000-00-00 | No | No | Current |
| 50090-0601-3 | 50090060103 | 10 TABLET, FILM COATED in 1 BOTTLE (50090-0601-3) | 2014-11-28 | 0000-00-00 | No | No | Current |
| 50090-0601-5 | 50090060105 | 28 TABLET, FILM COATED in 1 BOTTLE (50090-0601-5) | 2014-11-28 | 0000-00-00 | No | No | Current |