complete
- Product NDC
- 42507-321
- 11-digit product format
- 425070321
- Labeler code
- 42507
- Product ID
- 42507-321_f769b82f-e338-43b3-82cb-d3fec6443442
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- famotidine, calcium carbonate and magnesium hydroxide
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- HyVee Inc
- Application
- ANDA077355
- Marketing category
- ANDA
- Marketing start
- 2008-08-11
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- complete
- Brand name suffix
- dual action
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FAMOTIDINE | 800 mg/1 |
| CALCIUM CARBONATE | 10 mg/1 |
| MAGNESIUM HYDROXIDE | 165 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5QZO15J2Z8, H0G9379FGK, NBZ3QY004S |
| Rxcui | 283641 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42507-321-50 | completedual action | 50 in 1 BOTTLE | TABLET, CHEWABLE | 50 | | 4 |
| 42507-321-63 | completedual action | 25 in 1 BOTTLE | TABLET, CHEWABLE | 25 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CALCIUM CARBONATE | ACTIVE INGREDIENT | H0G9379FGK | COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [HYVEE INC] | 1 | |
| FAMOTIDINE | ACTIVE INGREDIENT | 5QZO15J2Z8 | COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [HYVEE INC] | 1 | |
| MAGNESIUM HYDROXIDE | ACTIVE INGREDIENT | NBZ3QY004S | COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [HYVEE INC] | 1 | |
| CALCIUM CATION | ACTIVE MOIETY | 2M83C4R6ZB | COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [HYVEE INC] | 1 | |
| FAMOTIDINE | ACTIVE MOIETY | 5QZO15J2Z8 | COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [HYVEE INC] | 1 | |
| HYDROXIDE ION | ACTIVE MOIETY | 9159UV381P | COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [HYVEE INC] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [HYVEE INC] | 1 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [HYVEE INC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [HYVEE INC] | 1 | |
| DEXTRATES | INACTIVE INGREDIENT | G263MI44RU | COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [HYVEE INC] | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [HYVEE INC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [HYVEE INC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [HYVEE INC] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [HYVEE INC] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [HYVEE INC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [HYVEE INC] | 1 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42507-321-50 | 42507032150 | 50 TABLET, CHEWABLE in 1 BOTTLE (42507-321-50) | 2026-02-25 | No | No | Historical |
| 42507-321-63 | 42507032163 | 25 in 1 BOTTLE | | | | Historical |