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 Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-082-63 | 3680000826336800008263 | 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 LLCNDC labeler code 36800
- 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.
About NDC 36800-082
- What is NDC 36800-082?
- 36800-082 is the product NDC for topcare dual action complete, Famotidine 10 mg/1 + 2 more ingredients tablet, chewable, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- topcare dual action complete (Famotidine, Calcium Carbonate, Magnesium Hydroxide).
- What is the active ingredient?
- Famotidine, Calcium carbonate, Magnesium hydroxide.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for topcare dual action complete?
- 1 other product NDC are listed under this name. See all topcare dual action complete NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other topcare dual action 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) |
|---|---|---|---|---|---|
| topcare dual action completefamotidine, calcium carbonate and magnesium hydroxide | Famotidine 10 mg/1 + 2 more ingredients | Tablet, ChewableOral | Topco Associates LLC | 36800-616 | 36800-0616-6336800-0616-71 |
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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