Loperamide Hydrochloride
- Product NDC
- 75907-097
- 11-digit product format
- 759070097
- Labeler code
- 75907
- Product ID
- 75907-097_cefb1fd9-768f-c7a4-b9b1-ab7faaa67308
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA213070
- Marketing category
- ANDA
- Marketing start
- 2021-10-22
- 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 | 978006 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75907-097-12 | Loperamide Hydrochloride | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | | 1 |
| 75907-097-12 | Loperamide Hydrochloride | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | | 1 |
| 75907-097-24 | Loperamide Hydrochloride | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | | 1 |
| 75907-097-24 | Loperamide Hydrochloride | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75907-097 | LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED [DR. REDDY'S LABORATORIES INC.] | 1 | Current NDC, 4 package rows | 20230628_356d9432-d948-4b88-b297-9161b845f86b.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 |
|---|
| 75907-097-12 | 75907009712 | 1 BLISTER PACK in 1 CARTON (75907-097-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 blister pack | 2023-08-01 | No | No | Historical |
| 75907-097-24 | 75907009724 | 2 BLISTER PACK in 1 CARTON (75907-097-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2 blister pack | 2023-08-01 | No | No | Historical |