Loperamide Hydrochloride
- Product NDC
- 68071-2700
- 11-digit product format
- 680712700
- Labeler code
- 68071
- Product ID
- 68071-2700_17dec409-07e2-7ecc-e063-6294a90ac555
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA215579
- Marketing category
- ANDA
- Marketing start
- 2021-12-01
- 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 | 978006 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-2700-0 | Loperamide Hydrochloride | 10 in 1 BOTTLE, PLASTIC | CAPSULE | 10 | | 3 |
| 68071-2700-1 | Loperamide Hydrochloride | 12 in 1 BOTTLE, PLASTIC | CAPSULE | 12 | | 3 |
| 68071-2700-2 | Loperamide Hydrochloride | 20 in 1 BOTTLE, PLASTIC | CAPSULE | 20 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-2700 | LOPERAMIDE HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 3 package rows | 20240508_df4e7076-fd25-aeb8-e053-2995a90a2aa0.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 |
|---|
| 68071-2700-0 | 68071270000 | 10 CAPSULE in 1 BOTTLE, PLASTIC (68071-2700-0) | 10 capsule | 2022-05-18 | | No | No | Current |
| 68071-2700-1 | 68071270001 | 12 CAPSULE in 1 BOTTLE, PLASTIC (68071-2700-1) | 12 capsule | 2022-05-18 | 0000-00-00 | No | No | Current |
| 68071-2700-2 | 68071270002 | 20 CAPSULE in 1 BOTTLE, PLASTIC (68071-2700-2) | 20 capsule | 2022-05-18 | 0000-00-00 | No | No | Current |