Ketorolac Tromethamine
- Product NDC
- 53002-6990
- 11-digit product format
- 530026990
- Labeler code
- 53002
- Product ID
- 53002-6990_d0fb4bef-06a1-482a-991a-5668530fadd7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- 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],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-6990-1 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d1-143d-f424-e053-dadaa90a57ce | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 53002-6990-2 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d1-143d-f424-e053-dadaa90a57ce | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 53002-6990-3 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d1-143d-f424-e053-dadaa90a57ce | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 53002-6990-1 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d1-143d-f424-e053-dadaa90a57ce | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 53002-6990-2 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d1-143d-f424-e053-dadaa90a57ce | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 53002-6990-3 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d1-143d-f424-e053-dadaa90a57ce | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 53002-6990-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d1-143d-f424-e053-dadaa90a57ce | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 53002-6990-2 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d1-143d-f424-e053-dadaa90a57ce | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 53002-6990-3 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d1-143d-f424-e053-dadaa90a57ce | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 53002-6990-1 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d1-143d-f424-e053-dadaa90a57ce | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 53002-6990-2 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d1-143d-f424-e053-dadaa90a57ce | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 53002-6990-3 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d1-143d-f424-e053-dadaa90a57ce | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 53002-6990-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-143d-f424-e053-dadaa90a57ce | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 53002-6990-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-143d-f424-e053-dadaa90a57ce | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 53002-6990-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-143d-f424-e053-dadaa90a57ce | 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 |
|---|
| 53002-6990-1 | Ketorolac Tromethamine | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 5 |
| 53002-6990-2 | Ketorolac Tromethamine | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 5 |
| 53002-6990-3 | Ketorolac Tromethamine | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-6990 | KETOROLAC TROMETHAMINE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 3 package rows | 20230609_a5220202-6eee-4a42-8d4a-8f7475dd1383.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 |
|---|
| 53002-6990-1 | 53002699001 | 10 TABLET, FILM COATED in 1 BOTTLE (53002-6990-1) | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-6990-2 | 53002699002 | 15 TABLET, FILM COATED in 1 BOTTLE (53002-6990-2) | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-6990-3 | 53002699003 | 20 TABLET, FILM COATED in 1 BOTTLE (53002-6990-3) | 2018-10-01 | 0000-00-00 | No | No | Current |