CareOne Diarrhea Control
- Product NDC
- 41520-813
- 11-digit product format
- 415200813
- Labeler code
- 41520
- Product ID
- 41520-813_9781fece-a022-4c74-b5ff-ea39a29b4b16
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Sales Company
- Application
- ANDA075232
- Marketing category
- ANDA
- Marketing start
- 2016-09-14
- 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
- CareOne Diarrhea Control
- 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 |
|---|
| 41520-813-53 | CareOne Diarrhea Control | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 5 |
| 41520-813-53 | CareOne Diarrhea Control | 12 in 1 CARTON | TABLET, FILM COATED | 12 | | 5 |
| 41520-813-62 | CareOne Diarrhea Control | 24 in 1 CARTON | TABLET, FILM COATED | 24 | | 5 |
| 41520-813-62 | CareOne Diarrhea Control | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 5 |
| 41520-813-67 | CareOne Diarrhea Control | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 5 |
| 41520-813-67 | CareOne Diarrhea Control | 48 in 1 BOTTLE | TABLET, FILM COATED | 48 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 41520-813 | CAREONE DIARRHEA CONTROL (LOPERAMIDE HCL) TABLET, FILM COATED [AMERICAN SALES COMPANY] | 4 | Current NDC, Legacy NDC, 6 package rows | 20200104_17569b2c-38f9-43bd-87ac-eb82b64866e6.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 |
|---|
| 41520-813-53 | 41520081353 | 12 BLISTER PACK in 1 CARTON (41520-813-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 12 blister pack | 2016-09-14 | 0000-00-00 | No | No | Current |
| 41520-813-62 | 41520081362 | 24 BLISTER PACK in 1 CARTON (41520-813-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 24 blister pack | 2016-09-14 | 0000-00-00 | No | No | Current |
| 41520-813-67 | 41520081367 | 1 BOTTLE in 1 CARTON (41520-813-67) > 48 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2016-09-14 | 0000-00-00 | No | No | Current |