Ibuprofen and Pseudoephedrine hydrochloride
- Product NDC
- 51660-423
- 11-digit product format
- 516600423
- Labeler code
- 51660
- Product ID
- 51660-423_2f1cab21-cfa7-0b0e-e063-6294a90a9ae6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ibuprofen and pseudoephedrine hydrochloride
- Dosage form
- TABLET, SUGAR COATED
- Route
- ORAL
- Labeler
- Ohm Laboratories Inc.
- Application
- ANDA074567
- Marketing category
- ANDA
- Marketing start
- 2001-10-13
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51660-423-21 | Ibuprofen and Pseudoephedrine hydrochloride | 20 in 1 BLISTER PACK | TABLET, SUGAR COATED | 20 | | 7 |
| 51660-423-41 | Ibuprofen and Pseudoephedrine hydrochloride | 40 in 1 BLISTER PACK | TABLET, SUGAR COATED | 40 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51660-423 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [OHM LABORATORIES INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250228_65ec0f85-7ca3-4adc-b152-a0ae2fd0692f.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 |
|---|
| 51660-423-21 | 51660042321 | 20 TABLET, SUGAR COATED in 1 BLISTER PACK (51660-423-21) | 2001-10-13 | 0000-00-00 | No | No | Current |
| 51660-423-41 | 51660042341 | 40 TABLET, SUGAR COATED in 1 BLISTER PACK (51660-423-41) | 2001-10-13 | 0000-00-00 | No | No | Current |