Over-the-counter drug · OTC MONOGRAPH DRUG
Gas Relief Ultra Strength (Simethicone 180 mg) NDC 53345-003
Dimethicone 410 180 mg/1 · Capsule, Liquid filled · Oral · Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)53345-003Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53345-0003Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53345-003-03 | 5334500030353345000303 | 1 BAG in 1 BOX (53345-003-03) / 25000 CAPSULE, LIQUID FILLED in 1 BAGMarketed from Apr 15, 2013 |
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)
- Gas Relief Ultra Strength
- Generic name (nonproprietary)
- simethicone 180 mg
- Active ingredients
- Dimethicone 410 — 180 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.NDC labeler code 53345
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 002
- Marketing start
- Listing expires
- Identifiers
- Product ID 53345-003_2752c444-2bca-7d23-e063-6394a90a9c67SPL ID 2752c444-2bca-7d23-e063-6394a90a9c67SPL set ID 2cfb8132-6de4-457d-880b-c870a38862adRxCUI 252294UNII TYU5GP6XGE
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
N453345000303followed by a unit qualifier and the quantityPackage 53345-0003-03. 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 for relief of: bloating pressure fullness stuffed feeling commonly referred to as gas
Excerpt only. Read the full label for complete information.
About NDC 53345-003
- What is NDC 53345-003?
- 53345-003 is the product NDC for Gas Relief Ultra Strength (simethicone 180 mg), Dimethicone 410 180 mg/1 capsule, liquid filled, listed with the FDA by Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gas Relief Ultra Strength (Simethicone 180 mg).
- What is the active ingredient?
- Dimethicone 410.
- Who is the labeler?
- Humanwell PuraCap Pharmaceutical (Wuhan), Ltd., NDC labeler code 53345. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gas Relief Ultra Strength?
- 12 other product NDCs are listed under this name. See all Gas Relief Ultra Strength NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gas Relief Ultra Strength products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gas Relief Ultra Strengthsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | H E B | 37808-874 | 37808-0874-60 |
| Gas Relief Ultra Strengthdimethicone | Dimethicone, Unspecified 180 mg/1 | Capsule, Liquid filledOral | TOPCO ASSOCIATES LLC | 36800-324 | 36800-0324-05 |
| Gas Relief Ultra Strengthsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | Safeway, Inc. | 21130-073 | 21130-0073-60 |
| Gas Relief Ultra Strengthsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | Rugby Laboratories, Inc. | 0536-1306 | 00536-1306-08 |
| Gas Relief Ultra Strengthsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | A-S Medication Solutions | 50090-6088 | 50090-6088-00 |
| Gas Relief Ultra Strengthsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | Walgreens | 0363-8740 | 00363-8740-2000363-8740-50 |
| Gas Relief Ultra Strengthsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | Walgreens | 0363-8730 | 00363-8730-20 |
| Gas Relief Ultra Strengthsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | P & L Development, LLC | 59726-773 | 59726-0773-20 |
| Gas Relief Ultra Strengthsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | Walgreens | 0363-0833 | 00363-0833-50 |
| Gas Relief Ultra Strengthsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | Walgreens | 0363-0932 | 00363-0932-2000363-0932-60 |
Other NDCs under M 002
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 |
|---|---|---|---|---|
| Extra Strength Gas Relief Cherrysimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Harris Teeter, LLC | 69256-134 |
| Gas Relief Extra Strengthsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Cardinal Health (Leader) 70000 | 70000-0529 |
| Extra Strength Gas Reliefsimethicone | Dimethicone, Unspecified 125 mg/1 | Tablet, ChewableOral | SAFEWAY | 21130-110 |
| Simethicone 250mg | Dimethicone 250 mg/1 | Capsule, Liquid filledOral | AMZ789 LLC | 73629-006 |
| FEVIA Gas Controlsimethicone | Dimethicone, Unspecified 250 mg/1 | Capsule, Liquid filledOral | VIVUNT PHARMA LLC | 82706-031 |
| Mylicon Infants Gas Relief Originalsimethicone | Dimethicone 20 mg/.3mL | EmulsionOral | Infirst Healthcare | 62372-630 |
| Simethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | AMZ789 LLC | 73629-002 |
| CVS PHARMACY Gas reliefsimethicone | Dimethicone, Unspecified 80 mg/1 | Tablet, ChewableOral | CVS | 51316-111 |
| Curist Gas Reliefsimethicone | Dimethicone 180 mg/180mg | Capsule, Liquid filledOral | Little Pharma. Inc. | 72559-041 |
| Gas Reliefsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Chain Drug Marketing Association, Inc. | 83324-325 |
| Gas Reliefsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Family Dollar (FAMILY WELLNESS) | 55319-555 |
| Gas Relief Extra Strengthsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Care One (Retail Business Services, LLC.) | 72476-897 |
| Curist Gas Reliefsimethicone | Dimethicone 250 mg/250mg | Capsule, Liquid filledOral | Little Pharma. Inc. | 72559-042 |
| mylanta gassimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Infirst Healthcare | 62372-554 |
| Ultra Strength Gas Reliefsimethicone | Dimethicone 180 mg/1 | CapsuleOral | BETTER LIVING BRANDS, LLC | 21130-717 |
| Simethicone | Dimethicone 80 mg/1 | Tablet, ChewableOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-649 |
| FEVIA Gas Controlsimethicone | Dimethicone, Unspecified 250 mg/1 | Capsule, Liquid filledOral | VIVUNT PHARMA LLC | 82706-031 |
| Mylicon Infants Gas Relief Dye Freesimethicone | Dimethicone 20 mg/.3mL | EmulsionOral | Infirst Healthcare | 62372-650 |
| QUITA COLICOS Gas RELIEF Dropssimethicone | Dimethicone 20 mg/.3mL | LiquidOral | DLC Laboratories, Inc. | 24286-1533 |
| Antiflatulentsimethicone | Dimethicone 80 mg/1 | Tablet, ChewableOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-650 |
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