Anti-Diarrheal
- Product NDC
- 66424-725
- 11-digit product format
- 664240725
- Labeler code
- 66424
- Product ID
- 66424-725_165d219c-0749-40ef-e063-6294a90a45a4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- SDA Laboratories, Inc.
- Application
- ANDA076497
- Marketing category
- ANDA
- Marketing start
- 2024-02-01
- 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 |
|---|
| 66424-725-24 | Anti-Diarrheal | 6 in 1 BLISTER PACK | TABLET | 6 | | 1 |
| 66424-725-24 | Anti-Diarrheal | 4 in 1 CARTON | TABLET | 4 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66424-725 | ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET [SDA LABORATORIES, INC.] | 1 | Current NDC, 2 package rows | 20240420_d954ff63-f096-45e8-a0b6-f22e323b113f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 66424-725-24 | 66424072524 | 4 BLISTER PACK in 1 CARTON (66424-725-24) / 6 TABLET in 1 BLISTER PACK | 4 blister pack | 2024-02-01 | No | No | Current |