Ketorolac Tromethamine
- Product NDC
- 45865-613
- 11-digit product format
- 458650613
- Labeler code
- 45865
- Product ID
- 45865-613_7d62291a-6194-458a-e053-2a91aa0a1af7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketorolac tromethamine
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Medsource Pharmaceuticals
- Application
- ANDA076109
- Marketing category
- ANDA
- Marketing start
- 2009-12-07
- Marketing end
- 0000-00-00
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 5 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 |
|---|
| 45865-613-01 | Ketorolac Tromethamine | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 1 |
| 45865-613-01 | Ketorolac Tromethamine | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45865-613 | KETOROLAC TROMETHAMINE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS] | 1 | Legacy NDC, 2 package rows | 20181220_7d62291a-6193-458a-e053-2a91aa0a1af7.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 |
|---|
| 45865-613-01 | 45865061301 | 1 BOTTLE, DROPPER in 1 CARTON (45865-613-01) > 5 mL in 1 BOTTLE, DROPPER | 2018-06-01 | 0000-00-00 | No | No | Current |