KETOROLAC TROMETHAMINE
- Product NDC
- 53002-7780
- 11-digit product format
- 530027780
- Labeler code
- 53002
- Product ID
- 53002-7780_f6996d93-ed57-4772-ae55-933ae1977f48
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketorolac tromethamine
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA076583
- Marketing category
- ANDA
- Marketing start
- 2009-11-05
- Marketing end
- 0000-00-00
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 5 mg/mL
- 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
- 2023-12-31
- 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 |
|---|
| 53002-7780-1 | KETOROLAC TROMETHAMINE | 5 mL in 1 BOTTLE, DROPPER | SOLUTION | 5 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-7780 | KETOROLAC TROMETHAMINE SOLUTION [RPK PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 1 package rows | 20220331_2f2bc309-6da3-4e44-92ce-aff2854bab61.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-7780-1 | 53002778001 | 5 mL in 1 BOTTLE, DROPPER (53002-7780-1) | 5 ml | 2021-01-01 | 0000-00-00 | No | No | Current |