Allergy
- Product NDC
- 63654-309
- 11-digit product format
- 636540309
- Labeler code
- 63654
- Product ID
- 63654-309_39201d37-e750-420b-8035-feb97bc77c21
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Selder, S.A. de C.V.
- Application
- ANDA076471
- Marketing category
- ANDA
- Marketing start
- 2014-12-16
- 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
- Allergy
- 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 | 311372 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63654-309-10 | Allergy | 1 in 1 CARTON | TABLET | 1 | | 4 |
| 63654-309-10 | Allergy | 10 in 1 BLISTER PACK | TABLET | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63654-309 | ALLERGY (LORATADINE) TABLET [SELDER, S.A. DE C.V.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20200617_afdb0117-dd2d-4ab1-a2f4-2a88b6bf5251.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 |
|---|
| 63654-309-10 | 63654030910 | 1 BLISTER PACK in 1 CARTON (63654-309-10) / 10 TABLET in 1 BLISTER PACK | 1 blister pack | 2014-12-16 | 0000-00-00 | No | No | Current |