topcare ibuprofen
- Product NDC
- 36800-705
- 11-digit product format
- 368000705
- Labeler code
- 36800
- Product ID
- 36800-705_4863e91d-f16d-4a61-8f24-5889fa59a2a3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ibuprofen
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA203599
- Marketing category
- ANDA
- Marketing start
- 2021-09-24
- Substance
- IBUPROFEN
- Active strength
- 200 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 ibuprofen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 310964 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-705-06 | topcare ibuprofen | 160 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 160 | | 3 |
| 36800-705-06 | topcare ibuprofen | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-705 | TOPCARE IBUPROFEN (IBUPROFEN) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20220715_0a24c758-fa11-4d9b-a8ee-eb059fe1fa5b.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 |
|---|
| 36800-705-06 | 36800070506 | 1 BOTTLE in 1 CARTON (36800-705-06) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE | 1 bottle | 2021-09-24 | 0000-00-00 | No | No | Current |