Loperamide Hydrochloride
- Product NDC
- 68998-123
- 11-digit product format
- 689980123
- Labeler code
- 68998
- Product ID
- 68998-123_0ea71997-4922-a72e-e063-6294a90a52da
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Marc Glassman, Inc.
- Application
- ANDA074091
- Marketing category
- ANDA
- Marketing start
- 2018-05-01
- 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
- Loperamide Hydrochloride
- 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 |
|---|
| 68998-123-24 | Loperamide Hydrochloride | 6 in 1 BLISTER PACK | TABLET | 6 | | 3 |
| 68998-123-24 | Loperamide Hydrochloride | 4 in 1 CARTON | TABLET | 4 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68998-123 | LOPERAMIDE HYDROCHLORIDE TABLET [MARC GLASSMAN, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240112_01efdce1-25ce-45ff-aeb6-f6fba00e59aa.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 |
|---|
| 68998-123-24 | 68998012324 | 4 BLISTER PACK in 1 CARTON (68998-123-24) / 6 TABLET in 1 BLISTER PACK | 4 blister pack | 2018-05-01 | 0000-00-00 | No | No | Current |