Loratadine
- Product NDC
- 25000-021
- 11-digit product format
- 250000021
- Labeler code
- 25000
- Product ID
- 25000-021_adf6c78c-edb1-4ffb-a934-d8cb772e621f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- MARKSANS PHARMA LIMITED
- Application
- ANDA206214
- Marketing category
- ANDA
- Marketing start
- 2016-10-01
- 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 | 828269 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25000-021-08 | Loratadine | 100 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 100 | | 3 |
| 25000-021-13 | Loratadine | 600 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 600 | | 3 |
| 25000-021-21 | Loratadine | 7500 in 1 BAG | CAPSULE, LIQUID FILLED | 7500 | | 3 |
| 25000-021-21 | Loratadine | 4 in 1 BOX | CAPSULE, LIQUID FILLED | 4 | | 3 |
| 25000-021-34 | Loratadine | 28 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 28 | | 3 |
| 25000-021-36 | Loratadine | 3 in 1 CARTON | CAPSULE, LIQUID FILLED | 3 | | 3 |
| 25000-021-36 | Loratadine | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | | 3 |
| 25000-021-46 | Loratadine | 8 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 8 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25000-021 | LORATADINE CAPSULE, LIQUID FILLED [MARKSANS PHARMA LIMITED] | 3 | Current NDC, Legacy NDC, 8 package rows | 20211117_c30907f9-1761-41e5-bd4e-2613e756e1c6.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 |
|---|
| 25000-021-08 | 25000002108 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-08) | | 2016-10-01 | 0000-00-00 | No | No | Current |
| 25000-021-13 | 25000002113 | 600 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-13) | | 2016-10-01 | 0000-00-00 | No | No | Current |
| 25000-021-21 | 25000002121 | 4 BAG in 1 BOX (25000-021-21) / 7500 CAPSULE, LIQUID FILLED in 1 BAG | 4 bag | 2016-10-01 | 0000-00-00 | No | No | Current |
| 25000-021-34 | 25000002134 | 28 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (25000-021-34) | | 2016-10-01 | 0000-00-00 | No | No | Current |
| 25000-021-36 | 25000002136 | 3 BLISTER PACK in 1 CARTON (25000-021-36) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 3 blister pack | 2020-10-17 | 0000-00-00 | No | No | Current |
| 25000-021-46 | 25000002146 | 8 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-46) | | 2016-10-01 | 0000-00-00 | No | No | Current |