Pseudoephedrine Hydrochloride
- Product NDC
- 46122-166
- 11-digit product format
- 461220166
- Labeler code
- 46122
- Product ID
- 46122-166_8b44b9ef-7b42-44da-b3cf-ad53f2a2ecdd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amerisource Bergen
- Application
- ANDA077442
- Marketing category
- ANDA
- Marketing start
- 2006-04-28
- Marketing end
- 0000-00-00
- Substance
- PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 120 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 6V9V2RYJ8N | PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN] | 1 | |
| PSEUDOEPHEDRINE | ACTIVE MOIETY | 7CUC9DDI9F | PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN] | 1 | |
| CASTOR OIL | INACTIVE INGREDIENT | D5340Y2I9G | PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46122-166 | PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN] | 4 | Legacy NDC | 20210618_34885466-1b89-46b6-9257-07067b111ec6.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 46122-166-60 | 46122016660 | 20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (46122-166-60) | 2006-04-28 | 0000-00-00 | No | No | Current |