Ibuprofen
- Product NDC
- 50844-353
- 11-digit product format
- 508440353
- Labeler code
- 50844
- Product ID
- 50844-353_5f8c5841-a57f-4394-bbc2-93fc48474282
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- L.N.K. International, Inc.
- Application
- ANDA075139
- Marketing category
- ANDA
- Marketing start
- 1999-03-01
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ibuprofen
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 310965 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50844-353-02 | Ibuprofen | 12 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 12 | | 13 |
| 50844-353-02 | Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 13 |
| 50844-353-16 | Ibuprofen | 1000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 1000 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Ibuprofen | ACTIVE INGREDIENT | WK2XYI10QM | IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] | 1 | |
| Ibuprofen | ACTIVE MOIETY | WK2XYI10QM | IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] | 1 | |
| Hypromellose | INACTIVE INGREDIENT | 3NXW29V3WO | IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] | 1 | |
| Lactose | INACTIVE INGREDIENT | J2B2A4N98G | IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] | 1 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] | 1 | |
| Polydextrose | INACTIVE INGREDIENT | VH2XOU12IE | IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] | 1 | |
| Polyethylene Glycol | INACTIVE INGREDIENT | 3WJQ0SDW1A | IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] | 1 | |
| Povidone | INACTIVE INGREDIENT | FZ989GH94E | IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] | 1 | |
| Starch, Corn | INACTIVE INGREDIENT | O8232NY3SJ | IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] | 1 | |
| Stearic Acid | INACTIVE INGREDIENT | 4ELV7Z65AP | IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] | 1 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] | 1 | |
| Triacetin | INACTIVE INGREDIENT | XHX3C3X673 | IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50844-353 | IBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] | 12 | Current NDC, Legacy NDC, 3 package rows | 20250130_c93da67f-f42e-4baa-976b-73c71ba6dd71.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50844-353-02 | 50844035302 | 1 BOTTLE, PLASTIC in 1 CARTON (50844-353-02) / 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 1999-03-01 | 0000-00-00 | No | No | Current |
| 50844-353-16 | 50844035316 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-353-16) | 1999-03-01 | 0000-00-00 | No | No | Current |