LORATADINE
- Product NDC
- 49483-686
- 11-digit product format
- 494830686
- Labeler code
- 49483
- Product ID
- 49483-686_6c562c37-86ca-42c2-e053-2a91aa0a8a8a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- LORATADINE
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- TIME CAP LABORATORIES INC
- Application
- ANDA206214
- Marketing category
- ANDA
- Marketing start
- 2016-10-13
- 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 |
|---|
| 49483-686-07 | LORATADINE | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | | 4 |
| 49483-686-30 | LORATADINE | 30 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49483-686 | LORATADINE CAPSULE, LIQUID FILLED [TIME CAP LABORATORIES INC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20180529_85b26cf3-448c-4d4f-93a2-aa89530ec1f1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49483-686-07 | 49483068607 | 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (49483-686-07) | 2016-10-13 | 0000-00-00 | No | No | Current |
| 49483-686-30 | 49483068630 | 30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (49483-686-30) | 2016-10-13 | 0000-00-00 | No | No | Current |