Ketorolac Tromethamine
- Product NDC
- 51655-170
- 11-digit product format
- 516550170
- Labeler code
- 51655
- Product ID
- 51655-170_4af43a96-9b8b-f47b-e063-6394a90a145b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA074754
- Marketing category
- ANDA
- Marketing start
- 2014-07-15
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ketorolac Tromethamine
- Listing expiration
- 2027-12-31
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 |
|---|
| 51655-170-20 | 2026-01-29 | C162847 | 48780-1 | 9d75b9d0-a015-f424-e053-dadaa90a57ce | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 51655-170-54 | 2026-01-29 | C162847 | 48780-1 | 9d75b9d0-a015-f424-e053-dadaa90a57ce | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 51655-170-20 | 2023-11-14 | C162847 | 48780-1 | 9d75b9d0-a015-f424-e053-dadaa90a57ce | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 51655-170-54 | 2023-11-14 | C162847 | 48780-1 | 9d75b9d0-a015-f424-e053-dadaa90a57ce | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 51655-170-20 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-a015-f424-e053-dadaa90a57ce | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 51655-170-54 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-a015-f424-e053-dadaa90a57ce | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 51655-170-20 | 2021-05-03 | C162847 | 48780-1 | 9d75b9d0-a015-f424-e053-dadaa90a57ce | Ketorolac Tromethamine Tablets USP, 10 mg Rx only |
| 51655-170-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a015-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 |
|---|
| 51655-170-20 | Ketorolac Tromethamine | 20 in 1 BOTTLE, DISPENSING | TABLET, FILM COATED | 20 | | 4 |
| 51655-170-54 | Ketorolac Tromethamine | 15 in 1 BOTTLE, DISPENSING | TABLET, FILM COATED | 15 | | 4 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-170 | KETOROLAC TROMETHAMINE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20231115_d17ed469-677b-4a2e-96a9-5cfd0f50ecd9.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 |
|---|
| 51655-170-20 | 51655017020 | 20 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (51655-170-20) | 2014-07-15 | 0000-00-00 | No | No | Current |
| 51655-170-54 | 51655017054 | 15 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (51655-170-54) | 2020-08-27 | 0000-00-00 | No | No | Current |