LORATADINE
- Product NDC
- 0536-1092
- 11-digit product format
- 005361092
- Labeler code
- 0536
- Product ID
- 0536-1092_11ebf12d-ead4-17d2-f1bf-6b2e55783df0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rugby Laboratories
- Application
- ANDA076471
- Marketing category
- ANDA
- Marketing start
- 2016-06-22
- Marketing end
- 2022-04-30
- Substance
- LORATADINE
- Active strength
- 10 mg/1
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0536-1092-01 | 00536109201 | 100 TABLET in 1 BOTTLE (0536-1092-01) | 100 tablet | 2017-02-08 | 2022-04-30 | No | No | Current |
| 0536-1092-03 | 00536109203 | 300 TABLET in 1 BOTTLE (0536-1092-03) | 300 tablet | 2016-06-23 | 2022-04-30 | No | No | Current |