Anti-Diarrheal
- Product NDC
- 53943-375
- 11-digit product format
- 539430375
- Labeler code
- 53943
- Product ID
- 53943-375_44ab447d-86d6-445e-b75d-94480ce8f5e8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide HCl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Discount Drug Mart
- Application
- ANDA076497
- Marketing category
- ANDA
- Marketing start
- 2019-12-13
- 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 |
|---|
| 53943-375-02 | Anti-Diarrheal | 6 in 1 BLISTER PACK | TABLET | 6 | | 8 |
| 53943-375-02 | Anti-Diarrheal | 2 in 1 CARTON | TABLET | 2 | | 8 |
| 53943-375-08 | Anti-Diarrheal | 6 in 1 BLISTER PACK | TABLET | 6 | | 8 |
| 53943-375-08 | Anti-Diarrheal | 4 in 1 CARTON | TABLET | 4 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53943-375 | ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [DISCOUNT DRUG MART] | 7 | Current NDC, Legacy NDC, 4 package rows | 20240809_91843b17-3c04-482c-a2ba-143193be1595.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 |
|---|
| 53943-375-02 | 53943037502 | 2 BLISTER PACK in 1 CARTON (53943-375-02) / 6 TABLET in 1 BLISTER PACK | 2 blister pack | 2019-12-13 | 0000-00-00 | No | No | Current |
| 53943-375-08 | 53943037508 | 4 BLISTER PACK in 1 CARTON (53943-375-08) / 6 TABLET in 1 BLISTER PACK | 4 blister pack | 2019-12-13 | 0000-00-00 | No | No | Current |