Ibuprofen
- Product NDC
- 68210-4200
- 11-digit product format
- 682104200
- Labeler code
- 68210
- Product ID
- 68210-4200_ee8ef0e9-537c-25d0-e053-2995a90a6b9f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Spirit Pharmaceuticals LLC
- Application
- ANDA091355
- Marketing category
- ANDA
- Marketing start
- 2022-06-15
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68210-4200-3 | Ibuprofen | 40 in 1 BOTTLE | TABLET, COATED | 40 | | 6 |
| 68210-4200-3 | Ibuprofen | 1 in 1 CARTON | TABLET, COATED | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68210-4200 | IBUPROFEN TABLET, COATED [SPIRIT PHARMACEUTICALS LLC] | 6 | Legacy NDC, 2 package rows | 20241215_70707e95-9289-4384-b79f-d8933e3776ff.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 |
|---|
| 68210-4200-3 | 68210420003 | 1 BOTTLE in 1 CARTON (68210-4200-3) > 40 TABLET, COATED in 1 BOTTLE | 1 bottle | 2022-06-15 | 0000-00-00 | No | No | Current |