ANTI-DIARRHEAL
- Product NDC
- 80513-375
- 11-digit product format
- 805130375
- Labeler code
- 80513
- Product ID
- 80513-375_84cde7cf-6628-45b6-9673-16ffef460a4c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide HCl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advanced Rx LLC
- Application
- ANDA076497
- Marketing category
- ANDA
- Marketing start
- 2025-01-03
- Substance
- LOPERAMIDE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ANTI-DIARRHEAL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LOPERAMIDE HYDROCHLORIDE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 77TI35393C |
| Rxcui | 978010 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80513-375-08 | ANTI-DIARRHEAL | 4 in 1 CARTON | TABLET | 4 | | 3 |
| 80513-375-08 | ANTI-DIARRHEAL | 6 in 1 BLISTER PACK | TABLET | 6 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80513-375 | ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [ADVANCED RX LLC] | 2 | Current NDC, 2 package rows | 20250108_148cb6b7-28e7-48e9-b464-f42daa90e5da.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80513-375-08 | 80513037508 | 4 BLISTER PACK in 1 CARTON (80513-375-08) / 6 TABLET in 1 BLISTER PACK | 4 blister pack | 2025-01-03 | No | No | Current |