leader anti diarrheal
- Product NDC
- 70000-0589
- 11-digit product format
- 700000589
- Labeler code
- 70000
- Product ID
- 70000-0589_6761d752-f529-41a7-9b33-73c79481d481
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cardinal Health 110, LLC. dba Leader
- Application
- ANDA075232
- Marketing category
- ANDA
- Marketing start
- 2021-10-07
- 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
- leader 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 |
|---|
| 70000-0589-1 | leader anti diarrheal | 24 in 1 CARTON | TABLET, FILM COATED | 24 | | 1 |
| 70000-0589-1 | leader anti diarrheal | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70000-0589 | LEADER ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CARDINAL HEALTH 110, LLC. DBA LEADER] | 1 | Current NDC, Legacy NDC, 2 package rows | 20211008_6761d752-f529-41a7-9b33-73c79481d481.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 |
|---|
| 70000-0589-1 | 70000058901 | 24 BLISTER PACK in 1 CARTON (70000-0589-1) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 24 blister pack | 2021-10-07 | 0000-00-00 | No | No | Current |