Topcare ibuprofen
- Product NDC
- 36800-685
- 11-digit product format
- 368000685
- Labeler code
- 36800
- Product ID
- 36800-685_b780ff97-a999-4527-9e0d-0337f4f8c1e1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA074937
- Marketing category
- ANDA
- Marketing start
- 1995-02-03
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-685-26 | Topcare ibuprofenchildrens | 120 mL in 1 BOTTLE | SUSPENSION | 120 | | 8 |
| 36800-685-26 | Topcare ibuprofenchildrens | 1 in 1 CARTON | SUSPENSION | 1 | | 8 |
| 36800-685-28 | Topcare ibuprofenchildrens | 150 mL in 1 BOTTLE | SUSPENSION | 150 | | 8 |
| 36800-685-28 | Topcare ibuprofenchildrens | 1 in 1 CARTON | SUSPENSION | 1 | | 8 |
| 36800-685-34 | Topcare ibuprofenchildrens | 240 mL in 1 BOTTLE | SUSPENSION | 240 | | 8 |
| 36800-685-34 | Topcare ibuprofenchildrens | 1 in 1 CARTON | SUSPENSION | 1 | | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-685 | TOPCARE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC] | 8 | Legacy NDC, 6 package rows | 20240229_34734759-7067-4e14-9533-e08ec9c2673a.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 |
|---|
| 36800-685-26 | 36800068526 | 1 BOTTLE in 1 CARTON (36800-685-26) > 120 mL in 1 BOTTLE | 1 bottle | 2011-05-13 | 0000-00-00 | No | No | Current |
| 36800-685-28 | 36800068528 | 1 BOTTLE in 1 CARTON (36800-685-28) > 150 mL in 1 BOTTLE | 1 bottle | 2013-03-12 | 2021-11-30 | No | No | Current |
| 36800-685-34 | 36800068534 | 240 mL in 1 BOTTLE | 240 ml | | | | | Historical |