topcare dual action complete
- Product NDC
- 36800-082
- 11-digit product format
- 368000082
- Labeler code
- 36800
- Product ID
- 36800-082_8ff82275-ff8b-4073-ab1d-5f802e0c21a4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Famotidine, Calcium Carbonate, Magnesium Hydroxide
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA077355
- Marketing category
- ANDA
- Marketing start
- 2016-02-29
- Substance
- CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE
- Active strength
- 800; 10; 165 mg/1; mg/1; mg/1
- Pharmacologic classes
- Calculi Dissolution Agent [EPC], Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- topcare dual action complete
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CALCIUM CARBONATE | 800 mg/1 |
| FAMOTIDINE | 10 mg/1 |
| MAGNESIUM HYDROXIDE | 165 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H0G9379FGK, 5QZO15J2Z8, NBZ3QY004S |
| Rxcui | 283641 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-082-63 | topcare dual action complete | 25 in 1 BOTTLE | TABLET, CHEWABLE | 25 | | 6 |
| 36800-082-71 | topcare dual action complete | 50 in 1 BOTTLE | TABLET, CHEWABLE | 50 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-082 | TOPCARE DUAL ACTION COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [TOPCO ASSOCIATES LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20220721_2c5a1694-d6e9-4679-b421-61eaad5403a4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 36800-082-63 | 36800008263 | 25 TABLET, CHEWABLE in 1 BOTTLE (36800-082-63) | 2016-02-29 | 0000-00-00 | No | No | Current |
| 36800-082-71 | 36800008271 | 50 TABLET, CHEWABLE in 1 BOTTLE (36800-082-71) | 2016-02-29 | 0000-00-00 | No | No | Current |