sunmark ibuprofen
- Product NDC
- 49348-196
- 11-digit product format
- 493480196
- Labeler code
- 49348
- Product ID
- 49348-196_dbc8bf08-a838-462a-80ae-d7a3155e6679
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Strategic Sourcing Services LLC
- Application
- ANDA072096
- Marketing category
- ANDA
- Marketing start
- 2003-06-24
- 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 Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON] | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49348-196 | SUNMARK IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [STRATEGIC SOURCING SERVICES LLC] | 6 | Legacy NDC | 20241225_a8507ff0-b9ab-415d-acbc-ea424e35d12c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49348-196-09 | 49348019609 | 1 BOTTLE in 1 CARTON (49348-196-09) > 50 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2003-06-24 | 0000-00-00 | No | No | Current |
| 49348-196-10 | 49348019610 | 1 BOTTLE in 1 CARTON (49348-196-10) > 100 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2003-08-11 | 0000-00-00 | No | No | Current |
| 49348-196-35 | 49348019635 | 500 TABLET, FILM COATED in 1 BOTTLE (49348-196-35) | | 2003-08-21 | 0000-00-00 | No | No | Current |