anti diarrheal
- Product NDC
- 0113-2224
- 11-digit product format
- 001132224
- Labeler code
- 0113
- Product ID
- 0113-2224_e47631c6-5e8d-48ce-a5f3-4482e9a7463c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- L. Perrigo Company
- Application
- ANDA075232
- Marketing category
- ANDA
- Marketing start
- 2018-06-25
- 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
- anti diarrheal
- 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 |
|---|
| 0113-2224-62 | anti diarrheal | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 4 |
| 0113-2224-62 | anti diarrheal | 24 in 1 CARTON | TABLET, FILM COATED | 24 | | 4 |
| 0113-2224-68 | anti diarrheal | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 4 |
| 0113-2224-68 | anti diarrheal | 36 in 1 CARTON | TABLET, FILM COATED | 36 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0113-2224 | ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY] | 4 | Current NDC, Legacy NDC, 4 package rows | 20200104_e5c96703-1487-4943-9b16-fa6a05e6b02e.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 |
|---|
| 0113-2224-62 | 00113222462 | 24 BLISTER PACK in 1 CARTON (0113-2224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 24 blister pack | 2019-12-17 | 0000-00-00 | No | No | Current |
| 0113-2224-68 | 00113222468 | 36 BLISTER PACK in 1 CARTON (0113-2224-68) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 36 blister pack | 2018-06-25 | 0000-00-00 | No | No | Current |