Loratadine
- Product NDC
- 21130-042
- 11-digit product format
- 211300042
- Labeler code
- 21130
- Product ID
- 21130-042_b0412b0b-32e8-49a6-b62a-717290693d7e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine Oral
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Better Living Brands LLC
- Application
- ANDA208931
- Marketing category
- ANDA
- Marketing start
- 2023-09-25
- Substance
- LORATADINE
- Active strength
- 5 mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Loratadine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LORATADINE | 5 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7AJO3BO7QN |
| Rxcui | 692783 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21130-042-24 | Loratadine | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 2 |
| 21130-042-24 | Loratadine | 1 in 1 CARTON | SOLUTION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21130-042 | LORATADINE (LORATADINE ORAL) SOLUTION [BETTER LIVING BRANDS LLC] | 2 | Current NDC, 2 package rows | 20230927_f7dc7a3d-6709-d7e7-e053-6394a90acde8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 21130-042-24 | 21130004224 | 1 BOTTLE in 1 CARTON (21130-042-24) / 120 mL in 1 BOTTLE | 1 bottle | 2023-09-25 | No | No | Historical |