Over-the-counter drug · ANDA
CareOne Diarrhea Control (Loperamide hcl) NDC 41520-813
Loperamide hydrochloride 2 mg/1 · Tablet, Film coated · Oral · American Sales Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41520-813-53 | 4152008135341520081353 | 12 BLISTER PACK in 1 CARTON (41520-813-53) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Sep 14, 2016 | |
| 41520-813-62 | 4152008136241520081362 | 24 BLISTER PACK in 1 CARTON (41520-813-62) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Sep 14, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- CareOne Diarrhea Control
- Generic name (nonproprietary)
- loperamide hcl
- Active ingredients
- Loperamide hydrochloride — 2 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- American Sales CompanyNDC labeler code 41520
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075232
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 41520-813_9781fece-a022-4c74-b5ff-ea39a29b4b16SPL ID 9781fece-a022-4c74-b5ff-ea39a29b4b16SPL set ID 17569b2c-38f9-43bd-87ac-eb82b64866e6RxCUI 978010UNII 77TI35393C
- Pharmacologic class
- Opioid Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N441520081353followed by a unit qualifier and the quantityPackage 41520-0813-53. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Use controls symptoms of diarrhea, including Travelers’ Diarrhea
Excerpt only. Read the full label for complete information.
About NDC 41520-813
- What is NDC 41520-813?
- 41520-813 is the product NDC for CareOne Diarrhea Control (loperamide hcl), Loperamide hydrochloride 2 mg/1 tablet, film coated, listed with the FDA by American Sales Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- CareOne Diarrhea Control (Loperamide HCl).
- What is the active ingredient?
- Loperamide hydrochloride.
- Who is the labeler?
- American Sales Company, NDC labeler code 41520. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for CareOne Diarrhea Control?
- 1 other product NDC are listed under this name. See all CareOne Diarrhea Control NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other CareOne Diarrhea Control products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| CareOne Diarrhea Controlloperamide hydrochloride | Loperamide hydrochloride 1 mg/7.5mL | SuspensionOral | American Sales Company | 41520-841 | 41520-0841-26 |
Other NDCs under ANDA 075232
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Good Sense anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | L. Perrigo Company | 0113-0224 |
| Leader Anti Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Cardinal Health 110, LLC. dba Leader | 70000-0225 |
| anti diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | CVS Pharmacy | 59779-960 |
| basic care loperamide hydrochlorideloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-224 |
| anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Redpharm Drug Inc | 67296-1472 |
| dg health anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Dolgencorp, LLC | 55910-224 |
| Good Sense anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8750 |
| anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Meijer Distribution Inc | 41250-224 |
| anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7725 |
| berkley and jensen anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | BJWC | 68391-224 |
| Anti Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | H E B | 37808-552 |
| anti diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | L. Perrigo Company | 0113-2224 |
| anti diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-1010 |
| Up and Up anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Target Corporation | 11673-224 |
| injoy diarrhea reliefloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | L. Perrigo Company | 0113-6004 |
| leader anti diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Cardinal Health 110, LLC. dba Leader | 70000-0589 |
| topcare anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Topco Associates LLC | 36800-224 |
| Imodium A-Dloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Kenvue Brands LLC | 50580-317 |
| anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Publix Super Markets Inc | 56062-224 |
| anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | HyVee Inc | 42507-224 |
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