Ibuprofen and Pseudoephedrine HCl
- Product NDC
- 58602-803
- 11-digit product format
- 586020803
- Labeler code
- 58602
- Product ID
- 58602-803_08c50304-67d6-4733-84e4-5a686afa04f3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen and Pseudoephedrine HCl
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Aurohealth LLC
- Application
- ANDA209235
- Marketing category
- ANDA
- Marketing start
- 2017-12-01
- 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 HCl
- 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 | 1299018 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58602-803-03 | Ibuprofen and Pseudoephedrine HCl | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | | 6 |
| 58602-803-08 | Ibuprofen and Pseudoephedrine HCl | 4 in 1 CARTON | CAPSULE, LIQUID FILLED | 4 | | 6 |
| 58602-803-13 | Ibuprofen and Pseudoephedrine HCl | 4 in 1 CARTON | CAPSULE, LIQUID FILLED | 4 | | 6 |
| 58602-803-67 | Ibuprofen and Pseudoephedrine HCl | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | | 6 |
| 58602-803-79 | Ibuprofen and Pseudoephedrine HCl | 8 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 8 | | 6 |
| 58602-803-83 | Ibuprofen and Pseudoephedrine HCl | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58602-803 | IBUPROFEN AND PSEUDOEPHEDRINE HCL CAPSULE, LIQUID FILLED [AUROHEALTH LLC] | 6 | Current NDC, Legacy NDC, 6 package rows | 20220208_6adf9292-b4af-4cb4-99f3-dda03734570a.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 |
|---|
| 58602-803-03 | 58602080303 | 1 BLISTER PACK in 1 CARTON (58602-803-03) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83) | 1 blister pack | 2020-01-17 | 0000-00-00 | No | No | Current |
| 58602-803-08 | 58602080308 | 4 BLISTER PACK in 1 CARTON (58602-803-08) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83) | 4 blister pack | 2017-12-01 | 0000-00-00 | No | No | Current |
| 58602-803-13 | 58602080313 | 4 BLISTER PACK in 1 CARTON (58602-803-13) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-79) | 4 blister pack | 2017-12-01 | 0000-00-00 | No | No | Current |
| 58602-803-67 | 58602080367 | 2 BLISTER PACK in 1 CARTON (58602-803-67) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83) | 2 blister pack | 2017-12-01 | 0000-00-00 | No | No | Current |
| 58602-803-79 | 58602080379 | 8 in 1 BLISTER PACK | | | | | | Historical |
| 58602-803-83 | 58602080383 | 10 in 1 BLISTER PACK | | | | | | Historical |