Anti-Diarrheal
- Product NDC
- 68016-058
- 11-digit product format
- 680160058
- Labeler code
- 68016
- Product ID
- 68016-058_f0fe4551-a400-5bec-e053-2a95a90a55df
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- LOPERAMIDE HYDROCHLORIDE
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Premier Value Alliance LLC
- Application
- NDA021855
- Marketing category
- NDA
- Marketing start
- 2018-10-25
- 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 | 978006 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68016-058-12 | Anti-Diarrheal | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | | 3 |
| 68016-058-12 | Anti-Diarrheal | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68016-058 | ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [PREMIER VALUE ALLIANCE LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20221230_0dd97bfb-67ce-472f-9b23-15f613bb3135.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 |
|---|
| 68016-058-12 | 68016005812 | 1 BLISTER PACK in 1 CARTON (68016-058-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 blister pack | 2018-10-25 | 0000-00-00 | No | No | Current |