Pseudoephedrine hydrochloride
- Product NDC
- 68196-204
- 11-digit product format
- 681960204
- Labeler code
- 68196
- Product ID
- 68196-204_b22ca9ba-71ee-41a5-8395-85eeea13f4a4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pseudoephedrine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- SAM'S WEST INC
- Application
- ANDA077442
- Marketing category
- ANDA
- Marketing start
- 2012-02-07
- 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
- Pseudoephedrine hydrochloride
- 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 |
|---|
| 68196-204-20 | Pseudoephedrine hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 1 |
| 68196-204-20 | Pseudoephedrine hydrochloride | 2 in 1 PACKAGE | TABLET, FILM COATED | 2 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68196-204 | PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED [SAM'S WEST INC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20190409_5a885a10-7751-44f1-b2d9-a918f27604df.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 |
|---|
| 68196-204-20 | 68196020420 | 2 BLISTER PACK in 1 PACKAGE (68196-204-20) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2012-02-07 | 0000-00-00 | No | No | Current |