Loperamide HCl
- Product NDC
- 50844-735
- 11-digit product format
- 508440735
- Labeler code
- 50844
- Product ID
- 50844-735_cb21f56f-f513-4fa1-817c-0e5c3ce660c5
- 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
- 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
- Loperamide HCl
- 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#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50844-735 | LOPERAMIDE HCL TABLET [L.N.K. INTERNATIONAL, INC.] | 12 | Current NDC, Legacy NDC, 12 package rows | 20240913_547c4197-f573-4b30-9e39-2ab11d343609.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 |
|---|
| 50844-735-02 | 50844073502 | 2 BLISTER PACK in 1 CARTON (50844-735-02) / 6 TABLET in 1 BLISTER PACK | 2 blister pack | 2005-05-03 | 0000-00-00 | No | No | Current |
| 50844-735-08 | 50844073508 | 4 BLISTER PACK in 1 CARTON (50844-735-08) / 6 TABLET in 1 BLISTER PACK | 4 blister pack | 2005-05-03 | 0000-00-00 | No | No | Current |
| 50844-735-19 | 50844073519 | 2 BLISTER PACK in 1 CARTON (50844-735-19) / 4 TABLET in 1 BLISTER PACK | 2 blister pack | 2005-05-03 | 0000-00-00 | No | No | Current |
| 50844-735-24 | 50844073524 | 1 BLISTER PACK in 1 CARTON (50844-735-24) / 2 TABLET in 1 BLISTER PACK | 1 blister pack | 2005-05-03 | 0000-00-00 | No | No | Current |
| 50844-735-44 | 50844073544 | 3 BLISTER PACK in 1 CARTON (50844-735-44) / 6 TABLET in 1 BLISTER PACK | 3 blister pack | 2005-05-03 | 0000-00-00 | No | No | Current |
| 50844-735-45 | 50844073545 | 1 BLISTER PACK in 1 CARTON (50844-735-45) / 6 TABLET in 1 BLISTER PACK | 1 blister pack | 2005-05-03 | 0000-00-00 | No | No | Current |