Loratadine
- Product NDC
- 51660-753
- 11-digit product format
- 516600753
- Labeler code
- 51660
- Product ID
- 51660-753_48a60b3d-d011-4d0f-84dc-414c713c76ba
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Ohm Laboratories Inc.
- Application
- ANDA210088
- Marketing category
- ANDA
- Marketing start
- 2018-06-01
- Substance
- LORATADINE
- Active strength
- 5 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7AJO3BO7QN |
| Rxcui | 665078 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51660-753-31 | Loratadine | 3 in 1 CARTON | TABLET, CHEWABLE | 3 | | 4 |
| 51660-753-31 | Loratadine | 10 in 1 BLISTER PACK | TABLET, CHEWABLE | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51660-753 | LORATADINE TABLET, CHEWABLE [OHM LABORATORIES INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20190726_b83de07d-37f4-42b4-b43e-29173454bef0.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 |
|---|
| 51660-753-31 | 51660075331 | 3 BLISTER PACK in 1 CARTON (51660-753-31) / 10 TABLET, CHEWABLE in 1 BLISTER PACK | 3 blister pack | 2018-06-01 | 0000-00-00 | No | No | Current |