Anti-Diarrheal
- Product NDC
- 46122-581
- 11-digit product format
- 461220581
- Labeler code
- 46122
- Product ID
- 46122-581_da57d294-64fd-f68f-e053-2a95a90ad396
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- LOPERAMIDE HYDROCHLORIDE
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- AMERISOURCE BERGEN
- Application
- NDA021855
- Marketing category
- NDA
- Marketing start
- 2019-02-15
- 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 |
|---|
| 46122-581-62 | Anti-Diarrheal | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | | 3 |
| 46122-581-62 | 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 |
|---|
| 46122-581 | ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AMERISOURCE BERGEN] | 3 | Current NDC, Legacy NDC, 2 package rows | 20220317_1a8f6a42-e74f-4725-b12e-b85c2d015191.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 |
|---|
| 46122-581-62 | 46122058162 | 2 BLISTER PACK in 1 CARTON (46122-581-62) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2 blister pack | 2019-02-15 | 0000-00-00 | No | No | Current |