Over-the-counter drug · OTC MONOGRAPH DRUG
Aluminum Hydroxide, Magnesium Hydroxide and Simethicone NDC 84415-010
aluminum hydroxide, magnesium hydroxide, and simethicone · Aluminum hydroxide 2400 mg/30mL + 2 more ingredients · Suspension · Oral · Everpharm LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84415-010-01 | 8441500100184415001001 | 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (84415-010-01) / 30 mL in 1 CUP, UNIT-DOSEMarketed from Jan 16, 2025 |
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)
- Aluminum Hydroxide, Magnesium Hydroxide and Simethicone
- Generic name (nonproprietary)
- aluminum hydroxide, magnesium hydroxide, and simethicone
- Active ingredients
- Aluminum hydroxide — 2400 mg/30mLMagnesium hydroxide — 2400 mg/30mLDimethicone — 240 mg/30mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Everpharm LLCNDC labeler code 84415
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M001.15
- 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 84415-010_2bda8639-5512-d3fd-e063-6294a90a04eeSPL ID 2bda8639-5512-d3fd-e063-6294a90a04eeSPL set ID 2bda74cb-e77d-46bb-e063-6394a90af580RxCUI 237870, 307746UNII NBZ3QY004S, 92RU3N3Y1O, 5QB0T2IUN0
- 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
N484415001001followed by a unit qualifier and the quantityPackage 84415-0010-01. 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)
Uses relieves • heartburn • sour stomach • acid indigestion • the symptoms referred to as gas
Excerpt only. Read the full label for complete information.
About NDC 84415-010
- What is NDC 84415-010?
- 84415-010 is the product NDC for Aluminum Hydroxide, Magnesium Hydroxide and Simethicone, Aluminum hydroxide 2400 mg/30mL + 2 more ingredients suspension, listed with the FDA by Everpharm LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Aluminum Hydroxide, Magnesium Hydroxide and Simethicone (Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone).
- What is the active ingredient?
- Aluminum hydroxide, Magnesium hydroxide, Dimethicone.
- Who is the labeler?
- Everpharm LLC, NDC labeler code 84415. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Aluminum Hydroxide, Magnesium Hydroxide and Simethicone?
- 5 other product NDCs are listed under this name. See all Aluminum Hydroxide, Magnesium Hydroxide and Simethicone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Aluminum Hydroxide, Magnesium Hydroxide and Simethicone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone | Aluminum hydroxide 1200 mg/30mL + 2 more ingredients | SuspensionOral | Major Pharmaceuticals | 0904-7557 | 00904-7557-73 |
| Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone | Aluminum hydroxide 200 mg/5mL + 2 more ingredients | SuspensionOral | American Health Packaging | 60687-877 | 60687-0877-76 |
| Aluminum Hydroxide, Magnesium Hydroxide and Simethiconealuminum hydroxide, magnesium hydroxide, and simethicone | Aluminum hydroxide 1200 mg/30mL + 2 more ingredients | SuspensionOral | Everpharm LLC | 84415-017 | 84415-0017-01 |
| Aluminum Hydroxide, Magnesium Hydroxide and Simethiconealuminum hydroxide, magnesium hydroxide, and simethicone | Aluminum hydroxide 1200 mg/30mL + 2 more ingredients | SuspensionOral | Rising Pharma Holdings, Inc. | 57237-316 | 57237-0316-31 |
| Aluminum Hydroxide, Magnesium Hydroxide and Simethiconealuminum hydroxide, magnesium hydroxide, and simethicone | Aluminum hydroxide 2400 mg/30mL + 2 more ingredients | SuspensionOral | Rising Pharma Holdings, Inc. | 57237-324 | 57237-0324-31 |
Other NDCs under M001.15
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 |
|---|---|---|---|---|
| Aluminum Hydroxide, Magnesium Hydroxide and Simethiconealuminum hydroxide, magnesium hydroxide, and simethicone | Aluminum hydroxide 1200 mg/30mL + 2 more ingredients | SuspensionOral | Rising Pharma Holdings, Inc. | 57237-316 |
| Aluminum Hydroxide, Magnesium Hydroxide and Simethiconealuminum hydroxide, magnesium hydroxide, and simethicone | Aluminum hydroxide 2400 mg/30mL + 2 more ingredients | SuspensionOral | Rising Pharma Holdings, Inc. | 57237-324 |