Anti-Diarrheal
- Product NDC
- 53117-248
- 11-digit product format
- 531170248
- Labeler code
- 53117
- Product ID
- 53117-248_1588de6a-189b-456d-9569-00332627fa50
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide HCl
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- First Aid Direct
- Application
- ANDA076497
- Marketing category
- ANDA
- Marketing start
- 2005-05-03
- 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 |
|---|
| 53117-248-86 | Anti-Diarrheal | 2 in 1 CARTON | TABLET, COATED | 2 | | 2 |
| 53117-248-86 | Anti-Diarrheal | 6 in 1 BLISTER PACK | TABLET, COATED | 6 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53117-248 | ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET, COATED [FIRST AID DIRECT] | 2 | Current NDC, Legacy NDC, 2 package rows | 20221108_952fa976-ac4c-4dfb-b689-12c5242498ac.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 |
|---|
| 53117-248-86 | 53117024886 | 2 BLISTER PACK in 1 CARTON (53117-248-86) / 6 TABLET, COATED in 1 BLISTER PACK | 2 blister pack | 2005-05-03 | 0000-00-00 | No | No | Current |