Loperamide Hydrochloride
- Product NDC
- 63187-462
- 11-digit product format
- 631870462
- Labeler code
- 63187
- Product ID
- 63187-462_4b48b484-e780-4b66-a6ca-35c5d61bcf41
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA074091
- Marketing category
- ANDA
- Marketing start
- 1993-02-01
- 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 |
|---|
| 63187-462-12 | Loperamide Hydrochloride | 12 in 1 BLISTER PACK | TABLET | 12 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-462 | LOPERAMIDE HYDROCHLORIDE TABLET [PROFICIENT RX LP] | 6 | Current NDC, Legacy NDC, 1 package rows | 20220528_82e65393-25b7-4114-9c71-5840ee8bad84.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 |
|---|
| 63187-462-12 | 63187046212 | 12 TABLET in 1 BLISTER PACK (63187-462-12) | 12 tablet | 2014-03-27 | 0000-00-00 | No | No | Current |