Loratadine
- Product NDC
- 63548-0753
- 11-digit product format
- 635480753
- Labeler code
- 63548
- Product ID
- 63548-0753_c24222bc-72ef-4c15-b7c2-9401fe5f40a6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PLD Acquisitions LLC DBA Av�ma Pharma Solutions
- Application
- ANDA075209
- Marketing category
- ANDA
- Marketing start
- 2018-10-30
- 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 | 311372 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63548-0753-0 | Loratadine | 300 in 1 BOTTLE, PLASTIC | TABLET | 300 | | 6 |
| 63548-0753-1 | Loratadine | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 6 |
| 63548-0753-3 | Loratadine | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63548-0753 | LORATADINE TABLET [PLD ACQUISITIONS LLC DBA AVÉMA PHARMA SOLUTIONS] | 6 | Current NDC, Legacy NDC, 3 package rows | 20230505_2edb53f8-7661-4e54-bb50-e03078bae3bf.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 |
|---|
| 63548-0753-0 | 63548075300 | 300 TABLET in 1 BOTTLE, PLASTIC (63548-0753-0) | 300 tablet | 2018-10-30 | 0000-00-00 | No | No | Current |
| 63548-0753-1 | 63548075301 | 100 TABLET in 1 BOTTLE, PLASTIC (63548-0753-1) | 100 tablet | 2018-10-30 | 0000-00-00 | No | No | Current |
| 63548-0753-3 | 63548075303 | 30 TABLET in 1 BOTTLE, PLASTIC (63548-0753-3) | 30 tablet | 2018-10-30 | 0000-00-00 | No | No | Current |