Ibuprofen
- Product NDC
- 57344-109
- 11-digit product format
- 573440109
- Labeler code
- 57344
- Product ID
- 57344-109_458c094e-5757-0b4a-e063-6394a90aa3f9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- AAA Pharmaceutical, Inc.
- Application
- ANDA079129
- Marketing category
- ANDA
- Marketing start
- 2012-10-01
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- 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 | 310965 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57344-109-02 | Ibuprofen | 50 in 1 BOTTLE, PLASTIC | TABLET, COATED | 50 | | 4 |
| 57344-109-02 | Ibuprofen | 1 in 1 CARTON | TABLET, COATED | 1 | | 4 |
| 57344-109-03 | Ibuprofen | 1 in 1 CARTON | TABLET, COATED | 1 | | 4 |
| 57344-109-03 | Ibuprofen | 100 in 1 BOTTLE, PLASTIC | TABLET, COATED | 100 | | 4 |
| 57344-109-05 | Ibuprofen | 500 in 1 BOTTLE, PLASTIC | TABLET, COATED | 500 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Ibuprofen | ACTIVE INGREDIENT | WK2XYI10QM | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| Ibuprofen | ACTIVE MOIETY | WK2XYI10QM | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| carboxymethylcellulose sodium | INACTIVE INGREDIENT | K679OBS311 | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| dextrose monohydrate | INACTIVE INGREDIENT | LX22YL083G | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| ferric oxide red | INACTIVE INGREDIENT | 1K09F3G675 | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| lecithin, soybean | INACTIVE INGREDIENT | 1DI56QDM62 | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| maltodextrin | INACTIVE INGREDIENT | 7CVR7L4A2D | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| povidone K30 | INACTIVE INGREDIENT | U725QWY32X | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| sodium starch glycolate type a corn | INACTIVE INGREDIENT | AG9B65PV6B | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| stearic acid | INACTIVE INGREDIENT | 4ELV7Z65AP | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| triacetin | INACTIVE INGREDIENT | XHX3C3X673 | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57344-109 | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 3 | Current NDC, Legacy NDC, 5 package rows | 20241210_fbc7fb61-d295-464b-9f3b-52262ed6f31a.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 |
|---|
| 57344-109-02 | 57344010902 | 1 BOTTLE, PLASTIC in 1 CARTON (57344-109-02) > 50 TABLET, COATED in 1 BOTTLE, PLASTIC | 2019-05-01 | 0000-00-00 | No | No | Current |
| 57344-109-03 | 57344010903 | 1 BOTTLE, PLASTIC in 1 CARTON (57344-109-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC | 2012-10-01 | 0000-00-00 | No | No | Current |
| 57344-109-05 | 57344010905 | 500 TABLET, COATED in 1 BOTTLE, PLASTIC (57344-109-05) | 2019-05-01 | 2027-09-30 | No | No | Current |