12 Hour Nasal Decongestant
- Product NDC
- 59779-703
- 11-digit product format
- 597790703
- Labeler code
- 59779
- Product ID
- 59779-703_dcfaf9dd-eada-4fd1-84f0-ef0bc2dc5029
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- CVS Pharmacy
- Application
- ANDA075153
- Marketing category
- ANDA
- Marketing start
- 1999-12-01
- 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
openFDA Listing Details
- Product ID
- 59779-703_dcfaf9dd-eada-4fd1-84f0-ef0bc2dc5029
- SPL ID
- dcfaf9dd-eada-4fd1-84f0-ef0bc2dc5029
- Product type
- HUMAN OTC DRUG
- Finished product
- Yes
- Brand name base
- 12 Hour Nasal Decongestant
- Generic name
- Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Marketing start
- 1999-12-01
- Marketing category
- ANDA
- Application number
- ANDA075153
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA]; alpha-Adrenergic Agonist [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | 120 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 6V9V2RYJ8N |
| Rxcui | 1049154 |
| Spl Set Id | 85955336-3f79-457d-822c-f8be019729d1 |
| Manufacturer Name | CVS Pharmacy |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 59779-703-52 | 10 BLISTER PACK in 1 CARTON (59779-703-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 1999-12-01 | No |
| 59779-703-60 | 20 BLISTER PACK in 1 CARTON (59779-703-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 2000-09-11 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 6V9V2RYJ8N | PSEUDOEPHEDRINE HYDROCHLORIDE | 345-78-8 | PSEUDOEPHEDRINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 59779-703-52 | 59779070352 | 10 BLISTER PACK in 1 CARTON (59779-703-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 10 blister pack | 1999-12-01 | No | No | Historical |
| 59779-703-60 | 59779070360 | 20 BLISTER PACK in 1 CARTON (59779-703-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 20 blister pack | 2000-09-11 | No | No | Historical |