Anti-diarrheal
- Product NDC
- 37835-131
- 11-digit product format
- 378350131
- Labeler code
- 37835
- Product ID
- 37835-131_358df35b-9290-7e92-e063-6394a90a6b07
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide HCl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- BI-MART
- Application
- ANDA076497
- Marketing category
- ANDA
- Marketing start
- 2025-05-01
- 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 |
|---|
| 37835-131-01 | Anti-diarrheal | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 37835-131-12 | Anti-diarrheal | 6 in 1 BLISTER PACK | TABLET | 6 | | 1 |
| 37835-131-12 | Anti-diarrheal | 2 in 1 CARTON | TABLET | 2 | | 1 |
| 37835-131-24 | Anti-diarrheal | 4 in 1 CARTON | TABLET | 4 | | 1 |
| 37835-131-24 | Anti-diarrheal | 6 in 1 BLISTER PACK | TABLET | 6 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 37835-131 | ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [BI-MART] | 1 | Current NDC, 5 package rows | 20250523_a3687b81-1f4d-49d5-a25f-b16560ab83d8.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 |
|---|
| 37835-131-01 | 37835013101 | 100 TABLET in 1 BOTTLE (37835-131-01) | 100 tablet | 2025-05-01 | No | No | Current |
| 37835-131-12 | 37835013112 | 2 BLISTER PACK in 1 CARTON (37835-131-12) / 6 TABLET in 1 BLISTER PACK | 2 blister pack | 2025-05-01 | No | No | Current |
| 37835-131-24 | 37835013124 | 4 BLISTER PACK in 1 CARTON (37835-131-24) / 6 TABLET in 1 BLISTER PACK | 4 blister pack | 2025-05-01 | No | No | Current |