Over-the-counter drug · OTC MONOGRAPH DRUG
Leader Gas relief (Simethicone) NDC 70000-0434
Dimethicone 80 mg/1 · Tablet, Chewable · Oral · CARDINAL HEALTH 110, LLC. DBA LEADER
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0434-1 | 7000004340170000043401 | 100 TABLET, CHEWABLE in 1 BOTTLE (70000-0434-1)Marketed from Jun 7, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Leader Gas relief
- Generic name (nonproprietary)
- simethicone
- Active ingredients
- Dimethicone — 80 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- CARDINAL HEALTH 110, LLC. DBA LEADERNDC labeler code 70000
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 002
- Marketing start
- Listing expires
- Other FDA classes
- Skin Barrier Activity (Physiologic effect)
- Identifiers
- Product ID 70000-0434_c598e7be-e58f-4812-8a05-f03d9303053bSPL ID c598e7be-e58f-4812-8a05-f03d9303053bSPL set ID 0163d372-222e-4a8d-a5cb-5a7af9a7068cRxCUI 314216UNII 92RU3N3Y1OUPC 0096295136067
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
N470000043401followed by a unit qualifier and the quantityPackage 70000-0434-01. 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(S) relieves: pressure bloating symptoms referred to as gas
Excerpt only. Read the full label for complete information.
About NDC 70000-0434
- What is NDC 70000-0434?
- 70000-0434 is the product NDC for Leader Gas relief (simethicone), Dimethicone 80 mg/1 tablet, chewable, listed with the FDA by CARDINAL HEALTH 110, LLC. DBA LEADER. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Leader Gas relief (Simethicone).
- What is the active ingredient?
- Dimethicone.
- Who is the labeler?
- CARDINAL HEALTH 110, LLC. DBA LEADER, NDC labeler code 70000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Leader Gas relief?
- 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 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 Reliefsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Harris Teeter, LLC | 69256-135 |
| Gas Relief Extra Strengthsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Cardinal Health (Leader) 70000 | 70000-0529 |
| Extra Strength Gas Reliefsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Geri-Care Pharmaceuticals, Corp | 57896-694 |
| QUITA COLICOS Gas RELIEF Dropssimethicone | Dimethicone 20 mg/.3mL | LiquidOral | DLC Laboratories, Inc. | 24286-1533 |
| Gas Relief Extra Strengthsimethicone | Dimethicone 125 mg/1 | Capsule, Liquid filledOral | Best Choice (Valu Merchandisers Company) | 63941-897 |
| Simethicone 80 mgsimethicone | Dimethicone 80 mg/1 | Tablet, ChewableOral | Proficient Rx LP | 82804-043 |
| Gas Relief Ultra Strengthsimethicone | Dimethicone 180 mg/1 | Capsule, Liquid filledOral | Walgreens | 0363-8730 |
| gas reliefsimethicone | Dimethicone, Unspecified 250 mg/1 | Capsule, Liquid filledOral | GLENMARK THERAPEUTICS INC., USA | 72657-482 |
| Simethicone | Dimethicone 250 mg/1 | Capsule, Liquid filledOral | WALGREEN CO. | 0363-9945 |
| gas reliefsimethicone | Dimethicone, Unspecified 125 mg/1 | Capsule, Liquid filledOral | GLENMARK THERAPEUTICS INC., USA | 72657-480 |
| Target Gas Relief Chews Mixed Berry and Strawberrysimethicone | Dimethicone 250 mg/1; Calcium carbonate 750 mg/1 | Tablet, ChewableOral | Target | 11673-548 |
| Ultra Strength Gas Reliefsimethicone | Dimethicone 180 mg/1 | CapsuleOral | BETTER LIVING BRANDS, LLC | 21130-717 |
| Simethicone 80Mgsimethicone | Dimethicone, Unspecified 80 mg/1 | Tablet, ChewableOral | Cardinal Health 107, LLC | 55154-2606 |
| gas reliefsimethicone | Dimethicone, Unspecified 180 mg/1 | Capsule, Liquid filledOral | GLENMARK THERAPEUTICS INC., USA | 72657-481 |
| extra strength Gas Relief cherry cremesimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Amerisource Bergen | 46122-811 |
| Alcohol prep pad | Isopropyl alcohol 70 g/1001 | ClothTopical | Target Corporation | 11673-139 |
| Maximum Strength Gas Reliefsimethicone | Dimethicone, Unspecified 250 mg/1 | Capsule, Liquid filledOral | Chain Drug Marketing Association, Inc. | 63868-975 |
| Gas Reliefsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Rite Aid Corporation | 11822-6080 |
| simethicone gas reliefsimethicone | Dimethicone 20 mg/.3mL | Suspension/ dropsOral | MOM Enterprises, LCC | 71444-788 |
| Gas Reliefsimethicone | Dimethicone 125 mg/1 | Tablet, ChewableOral | Chain Drug Marketing Association, Inc. | 83324-325 |
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