Loratadine ODT
- Product NDC
- 0536-1367
- 11-digit product format
- 005361367
- Labeler code
- 0536
- Product ID
- 0536-1367_f59f3400-da77-4eb7-be02-842071d87fae
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Rugby Laboratories
- Application
- ANDA208477
- Marketing category
- ANDA
- Marketing start
- 2022-10-06
- 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 ODT
- 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 | 311373 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0536-1367-07 | Loratadine ODT | 3 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 3 | | 1 |
| 0536-1367-07 | Loratadine ODT | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0536-1367 | LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [RUGBY LABORATORIES] | 1 | Current NDC, Legacy NDC, 2 package rows | 20221011_f59f3400-da77-4eb7-be02-842071d87fae.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 |
|---|
| 0536-1367-07 | 00536136707 | 3 BLISTER PACK in 1 CARTON (0536-1367-07) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 3 blister pack | 2022-10-06 | 0000-00-00 | No | No | Current |