leader acid reducer complete
- Product NDC
- 70000-0582
- 11-digit product format
- 700000582
- Labeler code
- 70000
- Product ID
- 70000-0582_60031720-d6d7-4794-b842-928619aa82eb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- famotidine, calcium carbonate and magnesium hydroxide
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Cardinal Health 110, LLC. dba Leader
- Application
- ANDA077355
- Marketing category
- ANDA
- Marketing start
- 2021-12-14
- 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
- leader acid reducer 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70000-0582-1 | leader acid reducer complete | 50 in 1 BOTTLE | TABLET, CHEWABLE | 50 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70000-0582 | LEADER ACID REDUCER COMPLETE (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [CARDINAL HEALTH 110, LLC. DBA LEADER] | 2 | Current NDC, Legacy NDC, 1 package rows | 20220715_a5420ef1-313f-4561-baf1-7ae017ea343a.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 |
|---|
| 70000-0582-1 | 70000058201 | 50 TABLET, CHEWABLE in 1 BOTTLE (70000-0582-1) | 2021-12-14 | 0000-00-00 | No | No | Current |