sinus 12 hour
- Product NDC
- 0113-2017
- 11-digit product format
- 001132017
- Labeler code
- 0113
- Product ID
- 0113-2017_98b199af-35e9-4582-9d3f-129d0696172f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pseudoephedrine HCl
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- L. Perrigo Company
- Application
- ANDA075153
- Marketing category
- ANDA
- Marketing start
- 2017-09-29
- Substance
- PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 120 mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], 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
- sinus 12 hour
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6V9V2RYJ8N |
| Rxcui | 1049154 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0113-2017-60 | sinus 12 hour | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 4 |
| 0113-2017-60 | sinus 12 hour | 20 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 20 | | 4 |
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 |
|---|
| 0113-2017-60 | 00113201760 | 20 BLISTER PACK in 1 CARTON (0113-2017-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 20 blister pack | 2017-09-29 | 0000-00-00 | No | No | Current |