Anti-Diarrheal
- Product NDC
- 50844-259
- 11-digit product format
- 508440259
- Labeler code
- 50844
- Product ID
- 50844-259_60b41d57-99b5-4cea-a996-58bd515fb65a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide HCl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- L.N.K. International, Inc.
- Application
- ANDA076497
- Marketing category
- ANDA
- Marketing start
- 2019-07-15
- 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 |
|---|
| 50844-259-02 | Anti-Diarrheal | 6 in 1 BLISTER PACK | TABLET | 6 | | 9 |
| 50844-259-02 | Anti-Diarrheal | 2 in 1 CARTON | TABLET | 2 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50844-259 | ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [L.N.K. INTERNATIONAL, INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250109_c03a9389-8b33-4ade-8ba0-8f303e161a08.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 |
|---|
| 50844-259-02 | 50844025902 | 2 BLISTER PACK in 1 CARTON (50844-259-02) / 6 TABLET in 1 BLISTER PACK | 2 blister pack | 2019-07-15 | 0000-00-00 | No | No | Current |