Pseudoephedrine Hydrochloride
- Product NDC
- 0904-6727
- 11-digit product format
- 009046727
- Labeler code
- 0904
- Product ID
- 0904-6727_3c446d89-47d5-b29f-e063-6294a90a2386
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pseudoephedrine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-01-31
- Marketing end
- 2026-12-31
- Substance
- PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SudoGest
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6V9V2RYJ8N |
| Rxcui | 1049160, 1049162 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-6727-60 | Pseudoephedrine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6727 | PSEUDOEPHEDRINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] | 4 | Current NDC, Legacy NDC, 1 package rows | 20241208_78faa497-6743-b85b-e053-2a91aa0ae822.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-6727-60 | 00904672760 | 100 TABLET in 1 BOTTLE (0904-6727-60) | 100 tablet | 2019-01-31 | 2026-12-31 | No | No | Current |