Over-the-counter drug · ANDA
CareOne Diarrhea and Gas Control (Loperamide hydrochloride, simethicone) NDC 41520-772
Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 · Tablet · Oral · American Sales Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41520-772-53 | 4152007725341520077253 | 12 BLISTER PACK in 1 CARTON (41520-772-53) / 1 TABLET in 1 BLISTER PACKMarketed from Jan 31, 2019 |
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 and Gas Control
- Generic name (nonproprietary)
- loperamide hydrochloride, simethicone
- Active ingredients
- Loperamide hydrochloride — 2 mg/1Dimethicone — 125 mg/1
- Dosage form
- Tablet
- 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 209837
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Agonists (Mechanism)Skin Barrier Activity (Physiologic effect)
- Identifiers
- Product ID 41520-772_81170c0a-6219-4612-af10-a46d1858e3e3SPL ID 81170c0a-6219-4612-af10-a46d1858e3e3SPL set ID dfa3db5a-cef6-4ed5-b9f1-a20b6d1657b3RxCUI 978001UNII 77TI35393C, 92RU3N3Y1O
- 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
N441520077253followed by a unit qualifier and the quantityPackage 41520-0772-53. 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)
Uses relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
Excerpt only. Read the full label for complete information.
About NDC 41520-772
- What is NDC 41520-772?
- 41520-772 is the product NDC for CareOne Diarrhea and Gas Control, Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 tablet, listed with the FDA by American Sales Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- CareOne Diarrhea and Gas Control (Loperamide hydrochloride, simethicone).
- What is the active ingredient?
- Loperamide hydrochloride, Dimethicone.
- 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 and Gas Control?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 209837
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 |
|---|---|---|---|---|
| anti diarrheal and anti gasloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Walgreen Company | 0363-1830 |
| anti diarrheal and anti gasloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | CVS Pharmacy | 69842-644 |
| anti diarrheal anti gasloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Rite Aid Corporation | 11822-1003 |
| Anti Diarrheal Anti Gasloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Kroger Company | 30142-581 |
| anti diarrheal anti gasloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | H E B | 37808-714 |
| anti diarrheal anti gasloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | HyVee Inc | 42507-699 |
| anti diarrheal plus anti gasloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Meijer Distribution Inc | 41250-375 |
| Basic Care Loperamide Hydrochloride and Simethiconeloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Amazon.com Services LLC | 72288-001 |
| dg health anti diarrheal anti gasloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Dolgencorp, LLC | 55910-383 |
| equaline anti diarrheal plus anti gasloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | United Natural Foods, Inc. dba UNFI | 41163-553 |
| foster and thrive anti diarrheal anti gasloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Strategic Sourcing Services LLC | 70677-1105 |
| good neighbor pharmacy anti diarrheal anti gasloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Amerisource Bergen | 46122-620 |
| good sense anti diarrheal anti gasloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | L. Perrigo Company | 0113-0087 |
| Good Sense Anti Diarrheal Anti Gasloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | L. Perrigo Company | 0113-1087 |
| loperamide hydrochloride and simethiconeloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Amazon.com Services LLC | 72288-728 |
| signature care anti diarrheal anti gasloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Safeway | 21130-183 |
| up and up anti diarrheal anti gasloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Target Corporation | 11673-646 |