Over-the-counter drug · OTC MONOGRAPH DRUG
Gelusil NDC 65197-300
alumina, magnesia, simethicone · Aluminum hydroxide 200 mg/1 + 3 more ingredients · Tablet, Chewable · Oral · WellSpring Pharmaceutical Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65197-300-10 | 65197030010 | 10 BLISTER PACK in 1 CARTON (65197-300-10) / 10 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Sep 24, 2008 | |
| 65197-300-11 | 65197030011 | 100 TABLET, CHEWABLE in 1 BOTTLE (65197-300-11)Marketed from Dec 1, 2018 |
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)
- Gelusil
- Generic name (nonproprietary)
- alumina, magnesia, simethicone
- Active ingredients
- Aluminum hydroxide — 200 mg/1Magnesium hydroxide — 200 mg/1Dimethicone, Unspecified — 24 mg/1Silicon dioxide — 1 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 001
- Marketing start
- Listing expires
- Other FDA classes
- Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Small Intestine Fluid/Electrolyte Absorption (Physiologic effect)Magnesium Ion Exchange Activity (Mechanism)Osmotic Activity (Mechanism)Skin Barrier Activity (Physiologic effect)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 65197-300_4406bf6b-b261-c6e1-e063-6294a90ae101SPL ID 4406bf6b-b261-c6e1-e063-6294a90ae101SPL set ID 92fbeec1-1562-40f3-9734-41f133d494f9RxCUI 211633, 307747UNII 5QB0T2IUN0, NBZ3QY004S, 92RU3N3Y1O, ETJ7Z6XBU4UPC 0365197300112
- Pharmacologic class
- Calculi Dissolution Agent; Osmotic Laxative
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
N465197030010followed by a unit qualifier and the quantityPackage 65197-0300-10. 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: Heartburn Sour stomach Acid indigestion Bloating, pressure and discomfort commonly referred to as gas
Excerpt only. Read the full label for complete information.
Other NDCs under M 001
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 |
|---|---|---|---|---|
| Sodium Bicarbonate | Sodium bicarbonate 1000 mg/g | PowderOral | Pharma Nobis, LLC | 82645-904 |
| Regular Strength Antacid And Antigasaluminum hydroxide, magnesium hydroxide, dimethicone | Aluminum hydroxide 200 mg/5mL + 2 more ingredients | SuspensionOral | STRATEGIC SOURCING SERVICES LLC | 70677-1063 |
| Antacidaluminum hydroxide, magnesium hydroxide, simethicone | Aluminum hydroxide 400 mg/10mL + 2 more ingredients | LiquidOral | Rugby Laboratories | 0536-1293 |
| Calcium Carbonate | Calcium carbonate 420 mg/1 | Tablet, ChewableOral | Allegiant Health | 69168-036 |
| Antacidaluminum hydroxide, magnesium hydroxide, simethicone | Aluminum hydroxide 400 mg/10mL + 2 more ingredients | LiquidOral | Guardian Drug Company | 53041-509 |
| Bismuth Subsalicylate | Bismuth subsalicylate 262 mg/1 | Tablet, Film coatedOral | CVS Pharmacy, Inc. | 69842-346 |
| Unishield Antacidcalcium carbonate | Calcium carbonate 420 mg/1 | Tablet, ChewableOral | Unishield | 49314-1013 |
| up and up extra strength smooth dissolving antacid Assorted Fruitcalcium carbonate | Calcium carbonate 750 mg/1 | Tablet, ChewableOral | Target corporation | 11673-715 |
| Good Neighbor Pharmacy Antacid Regular Strengthcalcium carbonate | Calcium carbonate 500 mg/1 | Tablet, ChewableOral | AmerisourceBergen Drug Corporation | 24385-485 |
| Sanar Baking Soda 8oz 100% puresodium bicarbonate | Sodium bicarbonate 616 mg/g | PowderOral | Evi Labs | 84178-104 |
| D-D Sudium Bicarbonate U.S.P. Bicarbonato De Soda Purosodium bicarbonate | Sodium bicarbonate 315 mg/g | PowderOral | Evi Labs | 84178-105 |
| Regular Strength Antacid Assorted Fruit Regular strength Antacidcalcium carbonate | Calcium carbonate 500 mg/1 | Tablet, ChewableOral | Hyvee Inc | 42507-350 |
| Antacid And Antigascalcium carbonate, magnesium hydroxide, simethicone | Calcium carbonate 800 mg/10mL + 2 more ingredients | LiquidOral | Geri-Care Pharmaceuticals, Corp | 57896-655 |
| Premier Value Extra Strength Original Flavoraluminum hydroxide and magnesium carbonate | Aluminum hydroxide 160 mg/1; Magnesium carbonate 105 mg/1 | Tablet, ChewableOral | PHARMACY VALUE ALLIANCE, LLC | 68016-105 |
| Genexa Antacid Maximum Strengthcalcium carbonate | Calcium carbonate 1000 mg/1 | Tablet, ChewableOral | Genexa Inc. | 69676-0072 |
| ADRIAN BICARBONATO SODIUM BICARBONATE USP-4 oz, 8 oz and 16 ozsodium bicarbonate | Sodium bicarbonate 315 mg/g | PowderOral | Evi Labs | 84178-106 |
| meijer extra strength Wintergreen Flavorcalcium carbonate | Calcium carbonate 750 mg/1 | Tablet, ChewableOral | MEIJER DISTRIBUTION INC | 41250-669 |
| Magnesium Oxide | Magnesium oxide 400 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-120 |
| Humco Sodium Bicarbonatesodium bicarbonate | Sodium bicarbonate 1000 mg/g | PowderOral | Humco Holding Group, Inc. | 0395-2685 |
| Dr Sana Alivio Digestivo Naranja UPSET STOMACHeffervescent antacid | Bicarbonate ion 2485 mg/5000mg | Granule, EffervescentOral | EVI LABS | 84178-112 |
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