Over-the-counter drug · ANDA
leader acid reducer complete NDC 70000-0582
famotidine, calcium carbonate and magnesium hydroxide · Famotidine 10 mg/1 + 2 more ingredients · Tablet, Chewable · Oral · Cardinal Health 110, LLC. dba Leader
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0582-1 | 7000005820170000058201 | 50 TABLET, CHEWABLE in 1 BOTTLE (70000-0582-1)Marketed from Dec 14, 2021 |
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 acid reducer complete
- Generic name (nonproprietary)
- famotidine, calcium carbonate and magnesium hydroxide
- Active ingredients
- Famotidine — 10 mg/1Calcium carbonate — 800 mg/1Magnesium hydroxide — 165 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
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077355
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)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)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 70000-0582_60031720-d6d7-4794-b842-928619aa82ebSPL ID 60031720-d6d7-4794-b842-928619aa82ebSPL set ID a5420ef1-313f-4561-baf1-7ae017ea343aRxCUI 283641UNII 5QZO15J2Z8, H0G9379FGK, NBZ3QY004S
- Pharmacologic class
- Calculi Dissolution Agent; Histamine-2 Receptor Antagonist; 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
N470000058201followed by a unit qualifier and the quantityPackage 70000-0582-01. 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 relieves heartburn associated with acid indigestion and sour stomach
Excerpt only. Read the full label for complete information.
About NDC 70000-0582
- What is NDC 70000-0582?
- 70000-0582 is the product NDC for leader acid reducer complete, Famotidine 10 mg/1 + 2 more ingredients 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 acid reducer complete (Famotidine, calcium carbonate and magnesium hydroxide).
- What is the active ingredient?
- Famotidine, Calcium carbonate, Magnesium hydroxide.
- 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 acid reducer complete?
- 1 other product NDC are listed under this name. See all leader acid reducer complete NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other leader acid reducer complete products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| leader acid reducer completefamotidine, calcium carbonate, magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | Cardinal Health 110, LLC. dba Leader | 70000-0416 | 70000-0416-01 |
Other NDCs under ANDA 077355
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 |
|---|---|---|---|---|
| Acid Reducer Completefamotidine, calcium carbonate and magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | Walgreen Company | 0363-0511 |
| Acid Reducer Completefamotidine, calcium carbonate, magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | Walgreen Company | 0363-0713 |
| Acid Reducer Completefamotidine, calcium carbonate, magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | Walgreen Company | 0363-4036 |
| Acid Reducer Completefamotidine, calcium carbonate and magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | Safeway | 21130-614 |
| acid reducer completefamotidine, calcium carbonate, magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | Safeway | 21130-786 |
| Acid Reducer Plus Antacidfamotidine, calcium carbonate and magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | CVS Pharmacy | 59779-738 |
| Acid Reducer Plus Antacidfamotidine, calcium carbonate, magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | CVS Pharmacy | 59779-862 |
| Basic Care Dual Action Completefamotidine, calcium carbonate and magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | Amazon.com Services LLC | 72288-321 |
| CareOne Acid Reducer Completefamotidine, calcium carbonate and magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | American Sales Company | 41520-409 |
| CareOne Acid Reducer Completefamotidine, calcium carbonate, magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | American Sales Company | 41520-617 |
| Complete Acid Reducerfamotidine, calcium carbonate and magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-407 |
| Complete Acid Reducerfamotidine, calcium carbonate, magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-588 |
| Complete Acid Reducerfamotidine, calcium carbonate, magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-732 |
| complete dual actionfamotidine, calcium carbonate and magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | HyVee Inc | 42507-321 |
| DG Health acid reducer completefamotidine, calcium carbonate and magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | Dolgencorp, LLC | 55910-808 |
| Dual Action Completefamotidine, calcium carbonate and magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | Kroger Company | 30142-040 |
| Dual Action Completefamotidine, calcium carbonate, magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | Kroger Company | 30142-213 |
| Dual Action Completefamotidine, calcium carbonate, magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | H E B | 37808-121 |
| Dual Action Completefamotidine, calcium carbonate and magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | H E B | 37808-503 |
| Dual Action Completefamotidine, calcium carbonate and magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | Meijer Distribution Inc | 41250-284 |
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