Over-the-counter drug · ANDA
anti diarrheal and anti gas (Loperamide hydrochloride, simethicone) NDC 0363-1830
Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 · Tablet · Oral · Walgreen Company
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0363-1830Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-1830Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-1830-53 | 0036318305300363183053 | 12 BLISTER PACK in 1 CARTON (0363-1830-53) / 1 TABLET in 1 BLISTER PACKMarketed from Oct 10, 2018 | |
| 0363-1830-62 | 0036318306200363183062 | 24 BLISTER PACK in 1 CARTON (0363-1830-62) / 1 TABLET in 1 BLISTER PACKMarketed from Jun 25, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- anti diarrheal and anti gas
- Generic name (nonproprietary)
- loperamide hydrochloride, simethicone
- Active ingredients
- Loperamide hydrochloride — 2 mg/1Dimethicone — 125 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Walgreen CompanyNDC labeler code 0363
- 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 0363-1830_580f2635-1560-43cd-825a-9e930369f958SPL ID 580f2635-1560-43cd-825a-9e930369f958SPL set ID 0999243a-c3be-41a6-b327-962e63d8c356RxCUI 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
N400363183053followed by a unit qualifier and the quantityPackage 00363-1830-53. 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 0363-1830
- What is NDC 0363-1830?
- 0363-1830 is the product NDC for anti diarrheal and anti gas, Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 tablet, listed with the FDA by Walgreen Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- anti diarrheal and anti gas (Loperamide hydrochloride, simethicone).
- What is the active ingredient?
- Loperamide hydrochloride, Dimethicone.
- Who is the labeler?
- Walgreen Company, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for anti diarrheal and anti gas?
- 1 other product NDC are listed under this name. See all anti diarrheal and anti gas NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other anti diarrheal and anti gas products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| anti diarrheal and anti gasloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | CVS Pharmacy | 69842-644 | 69842-0644-5369842-0644-62 |
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 | 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 |
| CareOne Diarrhea and Gas Controlloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | American Sales Company | 41520-772 |
| 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 |