Anti-Diarrheal
- Product NDC
- 80136-063
- 11-digit product format
- 801360063
- Labeler code
- 80136
- Product ID
- 80136-063_6ceb12f5-6d8d-4a45-a7cb-fa8ad0f10fec
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide HCl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Heartland Pharma Co.
- Application
- ANDA076497
- Marketing category
- ANDA
- Marketing start
- 2021-01-22
- Substance
- LOPERAMIDE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Anti-Diarrheal
- Listing expiration
- 2027-12-31
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 |
|---|
| 80136-063-11 | Anti-Diarrheal | 6 in 1 BLISTER PACK | TABLET | 6 | | 7 |
| 80136-063-11 | Anti-Diarrheal | 4 in 1 CARTON | TABLET | 4 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80136-063 | ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [NORTHEAST PHARMA] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250413_e360ba61-556a-4d7f-ab2e-2cb71656d868.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 |
|---|
| 80136-063-11 | 80136006311 | 4 BLISTER PACK in 1 CARTON (80136-063-11) / 6 TABLET in 1 BLISTER PACK | 4 blister pack | 2021-01-22 | 0000-00-00 | No | No | Current |