Ibuprofen
- Product NDC
- 81646-113
- 11-digit product format
- 816460113
- Labeler code
- 81646
- Product ID
- 81646-113_483e7336-2c5b-4468-b754-24b9be314992
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- PINNACLE PHARMA LLC
- Application
- ANDA076925
- Marketing category
- ANDA
- Marketing start
- 2004-12-08
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 100 mg/5mL
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 |
|---|
| 81646-113-20 | Ibuprofen | 20 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 20 | | 1 |
| 81646-113-43 | Ibuprofen | 1 in 1 CARTON | SUSPENSION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81646-113 | IBUPROFEN SUSPENSION [PINNACLE PHARMA LLC] | 1 | Legacy NDC, 2 package rows | 20210513_d40a898e-524a-4f6e-83a7-bab4ce5218d1.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 |
|---|
| 81646-113-20 | 81646011320 | 20 mL in 1 CUP, UNIT-DOSE | 20 ml | | | | | Historical |
| 81646-113-43 | 81646011343 | 1 CUP, UNIT-DOSE in 1 CARTON (81646-113-43) > 20 mL in 1 CUP, UNIT-DOSE (81646-113-20) | | 2004-12-08 | 0000-00-00 | No | No | Current |