nasal decongestant
- Product NDC
- 42507-054
- 11-digit product format
- 425070054
- Labeler code
- 42507
- Product ID
- 42507-054_ffcef8d5-c520-41be-82e1-dd2d5f8911ed
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- HyVee Inc
- Application
- ANDA075153
- Marketing category
- ANDA
- Marketing start
- 2000-09-11
- Marketing end
- 2020-05-04
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- nasal decongestant
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6V9V2RYJ8N |
| Rxcui | 1049154 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Status |
|---|
| 42507-054-52 | 42507005452 | 10 BLISTER PACK in 1 CARTON (42507-054-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 10 blister pack | 2026-05-29 | 0 | Current |
| 42507-054-60 | 42507005460 | 20 BLISTER PACK in 1 CARTON (42507-054-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 20 blister pack | 2000-09-11 | 0 | Current |