Loratadine
- Product NDC
- 16571-822
- 11-digit product format
- 165710822
- Labeler code
- 16571
- Product ID
- 16571-822_8b088034-c702-4b88-b4e3-421aa9739ec8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharmaceuticals, Inc
- Application
- ANDA214684
- Marketing category
- ANDA
- Marketing start
- 2022-03-10
- Substance
- LORATADINE
- Active strength
- 10 mg/1
- 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7AJO3BO7QN |
| Rxcui | 311372 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16571-822-01 | Loratadine | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 16571-822-03 | Loratadine | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 16571-822-30 | Loratadine | 300 in 1 BOTTLE | TABLET | 300 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-822 | LORATADINE TABLET [RISING PHARMACEUTICALS, INC] | 1 | Current NDC, Legacy NDC, 3 package rows | 20220310_d28128a3-af54-440e-9bd4-0fccf393d18a.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 |
|---|
| 16571-822-01 | 16571082201 | 100 TABLET in 1 BOTTLE (16571-822-01) | 100 tablet | 2022-03-10 | 0000-00-00 | No | No | Current |
| 16571-822-03 | 16571082203 | 30 TABLET in 1 BOTTLE (16571-822-03) | 30 tablet | 2022-03-10 | 0000-00-00 | No | No | Current |
| 16571-822-30 | 16571082230 | 300 TABLET in 1 BOTTLE (16571-822-30) | 300 tablet | 2022-03-10 | 0000-00-00 | No | No | Current |