Over-the-counter drug · ANDA
topcare dual action complete NDC 36800-082
famotidine, calcium carbonate, magnesium hydroxide · Famotidine 10 mg/1 + 2 more ingredients · Tablet, Chewable · Oral · Topco Associates LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)36800-082Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0082Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-082-63 | 36800008263 | 25 TABLET, CHEWABLE in 1 BOTTLE (36800-082-63)Marketed from Feb 29, 2016 |
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)
- topcare dual action complete
- Generic name (nonproprietary)
- famotidine, calcium carbonate, magnesium hydroxide
- Active ingredients
- Famotidine — 10 mg/1Calcium carbonate — 800 mg/1Magnesium hydroxide — 165 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- Topco Associates LLC
- 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 36800-082_8ff82275-ff8b-4073-ab1d-5f802e0c21a4SPL ID 8ff82275-ff8b-4073-ab1d-5f802e0c21a4SPL set ID 2c5a1694-d6e9-4679-b421-61eaad5403a4RxCUI 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
N436800008263followed by a unit qualifier and the quantityPackage 36800-0082-63. 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.
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 |
|---|---|---|---|---|
| CareOne Acid Reducer Completefamotidine, calcium carbonate and magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | American Sales Company | 41520-409 |
| Complete Acid Reducerfamotidine, calcium carbonate, magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-732 |
| Dual Action Completefamotidine, calcium carbonate, magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | Meijer Distribution Inc | 41250-690 |
| Equate Acid Reducer Completefamotidine, calcium carbonate, magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | Wal-Mart Stores Inc | 49035-546 |
| Dual Action Completefamotidine, calcium carbonate and magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | Kroger Company | 30142-040 |
| Acid Reducer Completefamotidine, calcium carbonate, magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | Walgreen Company | 0363-0713 |
| signature care acid reducer completefamotidine, calcium carbonate, magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | Safeway | 21130-546 |
| CareOne Acid Reducer Completefamotidine, calcium carbonate, magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | American Sales Company | 41520-617 |
| 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 | Walgreen Company | 0363-4036 |
| leader acid reducer completefamotidine, calcium carbonate and magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | Cardinal Health 110, LLC. dba Leader | 70000-0582 |
| foster and thrive acid reducer antacidfamotidine, calcium carbonate and magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | Strategic Sourcing Services LLC | 70677-1100 |
| Dual Action Completefamotidine, calcium carbonate and magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | Amazon.com Services LLC | 72288-774 |
| Good Sense Dual Action Completefamotidine, calcium carbonate and magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | L. Perrigo Company | 0113-0032 |
| Dual Action Completefamotidine, calcium carbonate and magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | H E B | 37808-503 |
| topcare dual action completefamotidine, calcium carbonate and magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | Topco Associates LLC | 36800-616 |
| Acid Reducer Plus Antacidfamotidine, calcium carbonate and magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | Rite Aid Corporation | 11822-0500 |
| 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 and magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | Meijer Distribution Inc | 41250-284 |
| dual action completefamotidine, calcium carbonate and magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | Publix Super Markets Inc | 56062-263 |
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