Anti-Diarrheal
- Product NDC
- 85828-248
- 11-digit product format
- 858280248
- Labeler code
- 85828
- Product ID
- 85828-248_bcd4ce8a-9aa8-4d74-9aad-d567a1de764c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide HCl
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Grocery Outlet
- Application
- ANDA076497
- Marketing category
- ANDA
- Marketing start
- 2026-03-19
- Substance
- LOPERAMIDE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Anti-Diarrheal
- Listing expiration
- 2027-12-31
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 |
|---|
| 85828-248-93 | Anti-Diarrheal | 2 in 1 CARTON | TABLET, COATED | 2 | | 1 |
| 85828-248-93 | Anti-Diarrheal | 12 in 1 BLISTER PACK | TABLET, COATED | 12 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85828-248-93 | 85828024893 | 2 BLISTER PACK in 1 CARTON (85828-248-93) / 12 TABLET, COATED in 1 BLISTER PACK | 2 blister pack | 2026-03-19 | No | No | Historical |