Pseudoephedrine Hydrochloride
- Product NDC
- 0363-6611
- 11-digit product format
- 003636611
- Labeler code
- 0363
- Product ID
- 0363-6611_95e1422f-6442-48a0-a624-bf10ece0adec
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- pseudoephedrine hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- WALGREEN CO.
- Application
- ANDA218854
- Marketing category
- ANDA
- Marketing start
- 2026-01-30
- Substance
- PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 240 mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pseudoephedrine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | 240 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6V9V2RYJ8N |
| Rxcui | 1049670 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0363-6611-10 | Pseudoephedrine Hydrochloride | 10 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 10 | | 2 |
| 0363-6611-10 | Pseudoephedrine Hydrochloride | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0363-6611-10 | 00363661110 | 1 BLISTER PACK in 1 CARTON (0363-6611-10) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2026-01-30 | No | No | Historical |