Loratadine
- Product NDC
- 0615-8217
- 11-digit product format
- 006158217
- Labeler code
- 0615
- Product ID
- 0615-8217_795e1026-4893-4066-891a-3dec5223db50
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA076301
- Marketing category
- ANDA
- Marketing start
- 2025-11-20
- 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
- Brand name suffix
- antihistamine
- 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 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8217-30 | Loratadineantihistamine | 6 in 1 BOX, UNIT-DOSE | TABLET | 6 | | 8 |
| 0615-8217-30 | Loratadineantihistamine | 5 in 1 BLISTER PACK | TABLET | 5 | | 8 |
| 0615-8217-39 | Loratadineantihistamine | 30 in 1 BLISTER PACK | TABLET | 30 | | 8 |
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 |
|---|
| 0615-8217-30 | 00615821730 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8217-30) / 5 TABLET in 1 BLISTER PACK | 6 blister pack | 2025-12-19 | | No | No | Historical |
| 0615-8217-39 | 00615821739 | 30 TABLET in 1 BLISTER PACK (0615-8217-39) | 30 tablet | 2025-11-20 | 0000-00-00 | No | No | Current |