Ketorolac Tromethamine
- Product NDC
- 50090-3397
- 11-digit product format
- 500903397
- Labeler code
- 50090
- Product ID
- 50090-3397_a87a8ce5-6f1b-453c-8b72-dc1aa2aedaf8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketorolac tromethamine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- A-S Medication Solutions
- Application
- ANDA204216
- Marketing category
- ANDA
- Marketing start
- 2017-09-29
- Marketing end
- 0000-00-00
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 30 mg/mL
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-3397-1 | Ketorolac Tromethamine | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 2 | | 1 |
| 50090-3397-1 | Ketorolac Tromethamine | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-3397 | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] | 1 | Legacy NDC, 2 package rows | 20190205_6dd21587-12ce-4f43-9761-43bc73d96906.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 |
|---|
| 50090-3397-1 | 50090339701 | 25 VIAL, SINGLE-DOSE in 1 CARTON (50090-3397-1) > 2 mL in 1 VIAL, SINGLE-DOSE | 2018-03-12 | 0000-00-00 | No | No | Current |