Loperamide Hydrochloride
- Product NDC
- 51079-690
- 11-digit product format
- 510790690
- Labeler code
- 51079
- Product ID
- 51079-690_3a865d0e-9176-11dd-e063-6394a90abcba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- loperamide hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Mylan Institutional Inc.
- Application
- ANDA072741
- Marketing category
- ANDA
- Marketing start
- 1997-03-10
- 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 |
|---|
| 51079-690-01 | Loperamide Hydrochloride | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 17 |
| 51079-690-20 | Loperamide Hydrochloride | 100 in 1 CARTON | CAPSULE | 100 | | 17 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51079-690 | LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.] | 16 | Current NDC, Legacy NDC, 2 package rows | 20240530_ad71d4ab-d293-47a2-8f3f-2c9f42d76e40.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 |
|---|
| 51079-690-01 | 51079069001 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 51079-690-20 | 51079069020 | 100 BLISTER PACK in 1 CARTON (51079-690-20) / 1 CAPSULE in 1 BLISTER PACK (51079-690-01) | 100 blister pack | 1997-03-10 | 0000-00-00 | No | No | Current |