Leader Allergy Relief D
- Product NDC
- 70000-0042
- 11-digit product format
- 700000042
- Labeler code
- 70000
- Product ID
- 70000-0042_57e2382c-9767-4be7-8d6b-db00e13b8276
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine hydrochloride, Pseudoephedrine hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Cardinal Health 110, LLC. dba Leader
- Application
- ANDA210719
- Marketing category
- ANDA
- Marketing start
- 2020-03-09
- Substance
- CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 5; 120 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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
- Leader Allergy Relief D
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CETIRIZINE HYDROCHLORIDE | 5 mg/1 |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 64O047KTOA, 6V9V2RYJ8N |
| Rxcui | 1014571 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70000-0042-1 | Leader Allergy Relief D | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 4 |
| 70000-0042-1 | Leader Allergy Relief D | 24 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 24 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70000-0042 | LEADER ALLERGY RELIEF D (CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER] | 4 | Current NDC, Legacy NDC, 2 package rows | 20230616_3152060c-f613-49db-91d4-356d2070c466.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 |
|---|
| 70000-0042-1 | 70000004201 | 24 BLISTER PACK in 1 CARTON (70000-0042-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 24 blister pack | 2020-03-09 | 0000-00-00 | No | No | Current |