topcare childrens ibuprofen
- Product NDC
- 36800-811
- 11-digit product format
- 368000811
- Labeler code
- 36800
- Product ID
- 36800-811_42eac10e-3ec4-4eaf-9e97-c50e2568430e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ibuprofen
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA076359
- Marketing category
- ANDA
- Marketing start
- 2019-09-04
- Substance
- IBUPROFEN
- Active strength
- 100 mg/1
- 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
- topcare childrens ibuprofen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 310963 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-811-62 | topcare childrens ibuprofen | 24 in 1 BOTTLE | TABLET, CHEWABLE | 24 | | 4 |
| 36800-811-62 | topcare childrens ibuprofen | 1 in 1 CARTON | TABLET, CHEWABLE | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-811 | TOPCARE CHILDRENS IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [TOPCO ASSOCIATES LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20220816_a88020c0-7982-4307-9836-74de66ea47a5.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 |
|---|
| 36800-811-62 | 36800081162 | 1 BOTTLE in 1 CARTON (36800-811-62) / 24 TABLET, CHEWABLE in 1 BOTTLE | 1 bottle | 2019-09-04 | 0000-00-00 | No | No | Current |