Alavert
- Product NDC
- 80070-100
- 11-digit product format
- 800700100
- Labeler code
- 80070
- Product ID
- 80070-100_b349557d-e1ba-435d-b0db-1cdce853b418
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- LORATADINE and PSEUDOEPHEDRINE SULFATE
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Foundation Consumer Brands
- Application
- ANDA076050
- Marketing category
- ANDA
- Marketing start
- 2021-12-15
- 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
- Alavert
- Brand name suffix
- Allergy and Congestion D-12 hour
- 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, 1242401 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80070-100-12 | Alavert Allergy and Congestion D-12 hour | 2 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 2 | | 2 |
| 80070-100-12 | Alavert Allergy and Congestion D-12 hour | 6 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 6 | | 2 |
| 80070-100-24 | Alavert Allergy and Congestion D-12 hour | 4 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 4 | | 2 |
| 80070-100-24 | Alavert Allergy and Congestion D-12 hour | 6 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 6 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80070-100 | ALAVERT ALLERGY AND CONGESTION D-12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [FOUNDATION CONSUMER BRANDS] | 2 | Current NDC, Legacy NDC, 4 package rows | 20211215_1a669f3c-36a6-439e-843d-47638fa217e8.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 |
|---|
| 80070-100-12 | 80070010012 | 2 BLISTER PACK in 1 CARTON (80070-100-12) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2021-12-15 | 0000-00-00 | No | No | Current |
| 80070-100-24 | 80070010024 | 4 BLISTER PACK in 1 CARTON (80070-100-24) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 4 blister pack | 2021-12-15 | 0000-00-00 | No | No | Current |