Caldolor
- Product NDC
- 66220-284
- 11-digit product format
- 662200284
- Labeler code
- 66220
- Product ID
- 66220-284_42d97e40-3617-496a-96e7-d95cbd530bc6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ibuprofen
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Cumberland Pharmaceuticals Inc.
- Application
- NDA022348
- Marketing category
- NDA
- Marketing start
- 2020-01-01
- Substance
- IBUPROFEN
- Active strength
- 800 mg/200mL
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Caldolor
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 800 mg/200mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 854183, 854187, 2178273, 2178275 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66220-284-11 | Caldolor | 200 mL in 1 BAG | INJECTION | 200 | | 16 |
| 66220-284-22 | Caldolor | 20 in 1 CASE | INJECTION | 20 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66220-284 | CALDOLOR (IBUPROFEN) INJECTION [CUMBERLAND PHARMACEUTICALS INC.] | 16 | Current NDC, Legacy NDC, 2 package rows | 20250216_1eaa7790-f1a1-4f51-b10a-cbbaf033f684.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 |
|---|
| 66220-284-11 | 66220028411 | 200 mL in 1 BAG | 200 ml | | | | | Historical |
| 66220-284-22 | 66220028422 | 20 BAG in 1 CASE (66220-284-22) / 200 mL in 1 BAG (66220-284-11) | 20 bag | 2020-01-01 | 0000-00-00 | No | No | Current |