Leader Allergy Relief D12
- Product NDC
- 70000-0504
- 11-digit product format
- 700000504
- Labeler code
- 70000
- Product ID
- 70000-0504_ae900734-0351-4a74-98a0-4af543e1882d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- loratadine, Pseudoephedrine sulfate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Cardinal Health 110, LLC. dba Leader
- Application
- ANDA076050
- Marketing category
- ANDA
- Marketing start
- 2020-01-09
- Substance
- LORATADINE; PSEUDOEPHEDRINE SULFATE
- Active strength
- 5; 120 mg/1; 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
- Leader Allergy Relief D12
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LORATADINE | 5 mg/1 |
| PSEUDOEPHEDRINE SULFATE | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7AJO3BO7QN, Y9DL7QPE6B |
| Rxcui | 1242399 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70000-0504-1 | Leader Allergy Relief D12 | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 3 |
| 70000-0504-1 | Leader Allergy Relief D12 | 10 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 10 | | 3 |
| 70000-0504-2 | Leader Allergy Relief D12 | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 3 |
| 70000-0504-2 | Leader Allergy Relief D12 | 20 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 20 | | 3 |
| 70000-0504-3 | Leader Allergy Relief D12 | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 3 |
| 70000-0504-3 | Leader Allergy Relief D12 | 30 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70000-0504 | LEADER ALLERGY RELIEF D12 (LORATADINE, PSEUDOEPHEDRINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER] | 3 | Current NDC, Legacy NDC, 6 package rows | 20210618_98bd6186-2bd2-4f46-99df-f509bb00e03a.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 |
|---|
| 70000-0504-1 | 70000050401 | 10 BLISTER PACK in 1 CARTON (70000-0504-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 10 blister pack | 2020-01-09 | 0000-00-00 | No | No | Current |
| 70000-0504-2 | 70000050402 | 20 BLISTER PACK in 1 CARTON (70000-0504-2) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 20 blister pack | 2020-01-09 | 0000-00-00 | No | No | Current |
| 70000-0504-3 | 70000050403 | 30 BLISTER PACK in 1 CARTON (70000-0504-3) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 30 blister pack | 2020-01-09 | 0000-00-00 | No | No | Current |