Ibuprofen and Pseudoephedrine Hydrochloride
- Product NDC
- 11822-0084
- 11-digit product format
- 118220084
- Labeler code
- 11822
- Product ID
- 11822-0084_61dd37ef-591d-42c8-9bdc-bd2a6073e63b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen and Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Rite-Aid
- Application
- ANDA074567
- Marketing category
- ANDA
- Marketing start
- 2018-02-01
- Substance
- IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 200; 30 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-Adrenergic Agonist [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 and Pseudoephedrine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 200 mg/1 |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM, 6V9V2RYJ8N |
| Rxcui | 1299021 |
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 |
|---|
| 11822-0084-5 | Ibuprofen and Pseudoephedrine Hydrochloride | 1 in 1 CARTON | TABLET, COATED | 1 | | 2 |
| 11822-0084-5 | Ibuprofen and Pseudoephedrine Hydrochloride | 20 in 1 BLISTER PACK | TABLET, COATED | 20 | | 2 |
| 11822-0084-6 | Ibuprofen and Pseudoephedrine Hydrochloride | 1 in 1 CARTON | TABLET, COATED | 1 | | 2 |
| 11822-0084-6 | Ibuprofen and Pseudoephedrine Hydrochloride | 40 in 1 BLISTER PACK | TABLET, COATED | 40 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 11822-0084 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [RITE-AID] | 2 | Current NDC, Legacy NDC, 4 package rows | 20220129_483c3bb7-529e-4684-80e1-6646b050988e.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 |
|---|
| 11822-0084-5 | 11822008405 | 1 BLISTER PACK in 1 CARTON (11822-0084-5) / 20 TABLET, COATED in 1 BLISTER PACK | 1 blister pack | 2018-02-01 | 0000-00-00 | No | No | Current |
| 11822-0084-6 | 11822008406 | 1 BLISTER PACK in 1 CARTON (11822-0084-6) / 40 TABLET, COATED in 1 BLISTER PACK | 1 blister pack | 2018-02-01 | 0000-00-00 | No | No | Current |