Dye Free Childrens Ibuprofen
- Product NDC
- 68094-600
- 11-digit product format
- 680940600
- Labeler code
- 68094
- Product ID
- 68094-600_df2a68e8-8400-4e49-ba13-bd66284bec52
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Precision Dose Inc.
- Application
- ANDA074937
- Marketing category
- ANDA
- Marketing start
- 2015-08-26
- Substance
- IBUPROFEN
- Active strength
- 100 mg/5mL
- 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
- Dye Free Childrens Ibuprofen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 100 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 197803 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68094-600-59 | Dye Free Childrens Ibuprofen | 5 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 5 | | 7 |
| 68094-600-61 | Dye Free Childrens Ibuprofen | 10 in 1 CASE | SUSPENSION | 10 | | 7 |
| 68094-600-61 | Dye Free Childrens Ibuprofen | 10 in 1 TRAY | SUSPENSION | 10 | | 7 |
| 68094-600-62 | Dye Free Childrens Ibuprofen | 10 in 1 TRAY | SUSPENSION | 10 | | 7 |
| 68094-600-62 | Dye Free Childrens Ibuprofen | 3 in 1 CASE | SUSPENSION | 3 | | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68094-600 | DYE FREE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.] | 7 | Current NDC, Legacy NDC, 5 package rows | 20250215_eccee4c6-aa94-468a-aebd-265d7a9efb6d.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 |
|---|
| 68094-600-59 | 68094060059 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | | Historical |
| 68094-600-61 | 68094060061 | 10 TRAY in 1 CASE (68094-600-61) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-600-59) | 10 tray | 2015-08-26 | 0000-00-00 | No | No | Current |
| 68094-600-62 | 68094060062 | 3 TRAY in 1 CASE (68094-600-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-600-59) | 3 tray | 2015-08-26 | 0000-00-00 | No | No | Current |