leader 12 hour nasal decongestant
- Product NDC
- 70000-0475
- 11-digit product format
- 700000475
- Labeler code
- 70000
- Product ID
- 70000-0475_e928de5f-8b3c-4b4b-bde9-8bc98db561d7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Cardinal Health 110, LLC. dba Leader
- Application
- ANDA075153
- Marketing category
- ANDA
- Marketing start
- 2019-02-11
- Marketing end
- 2027-03-31
- Substance
- PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 120 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
- leader 12 hour nasal decongestant
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 |
|---|
| 70000-0475-1 | leader 12 hour nasal decongestant | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 4 |
| 70000-0475-1 | leader 12 hour nasal decongestant | 10 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70000-0475 | LEADER 12 HOUR NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER] | 3 | Current NDC, Legacy NDC, 2 package rows | 20210620_8b8d374c-592e-44fc-a6cc-9f9e73ef914c.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 |
|---|
| 70000-0475-1 | 70000047501 | 10 BLISTER PACK in 1 CARTON (70000-0475-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 10 blister pack | 2019-02-11 | 2027-03-31 | No | No | Current |