Over-the-counter drug · ANDA
Heartburn Relief (Famotidine) NDC 83059-0031
Famotidine 10 mg/1 · Tablet, Film coated · Oral · Shield Pharmaceuticals Corp
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83059-0031-5 | 8305900310583059003105 | 1 BOTTLE in 1 PACKAGE (83059-0031-5) / 50 TABLET, FILM COATED in 1 BOTTLEMarketed from Jun 11, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Heartburn Relief
- Generic name (nonproprietary)
- famotidine
- Active ingredients
- Famotidine — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Shield Pharmaceuticals CorpNDC labeler code 83059
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215766
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 83059-0031_4276c109-6851-5045-e063-6294a90a592eSPL ID 4276c109-6851-5045-e063-6294a90a592eSPL set ID a12ec91d-244f-45c5-8590-d1e4485fe361RxCUI 199047UNII 5QZO15J2Z8UPC 0769165167262
- Pharmacologic class
- Histamine-2 Receptor Antagonist
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
N483059003105followed by a unit qualifier and the quantityPackage 83059-0031-05. 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)
Uses relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages
Excerpt only. Read the full label for complete information.
About NDC 83059-0031
- What is NDC 83059-0031?
- 83059-0031 is the product NDC for Heartburn Relief (famotidine), Famotidine 10 mg/1 tablet, film coated, listed with the FDA by Shield Pharmaceuticals Corp. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Heartburn Relief (Famotidine).
- What is the active ingredient?
- Famotidine.
- Who is the labeler?
- Shield Pharmaceuticals Corp, NDC labeler code 83059. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Heartburn Relief?
- 8 other product NDCs are listed under this name. See all Heartburn Relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Heartburn Relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Heartburn Relieffamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Shield Pharmaceuticals Corp | 83059-0185 | 83059-0185-01 |
| Heartburn Reliefaluminum hydroxide and magnesium carbonate | Aluminum hydroxide 254 mg/5mL; Magnesium carbonate 237.5 mg/5mL | SuspensionOral | GERI-CARE PHARMACEUTICALS, CORP | 57896-565 | 57896-0565-12 |
| Heartburn Relieffamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Shield Pharmaceuticals Corp | 83059-0005 | 83059-0005-05 |
| Heartburn Reliefaluminum hydroxide and magnesium carbonate | Aluminum hydroxide 254 mg/5mL; Magnesium carbonate 237.5 mg/5mL | SuspensionOral | CHAIN DRUG MARKETING ASSOCIATION | 63868-565 | 63868-0565-12 |
| heartburn relieffamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Meijer Distribution Inc | 41250-493 | 41250-0493-6541250-0493-72 |
| heartburn relieffamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Meijer Distribution Inc | 41250-712 | 41250-0712-0241250-0712-7141250-0712-78 |
| Heartburn Reliefcarbo more | Activated charcoal 6 [hp_X]/1 + 5 more ingredients | Tablet, Orally disintegratingOral | TRP Company | 17312-030 | 17312-0030-14 |
| heartburn reliefcimetidine | Cimetidine 200 mg/1 | Tablet, Film coatedOral | CVS Pharmacy | 59779-022 | 59779-0022-7259779-0022-76 |
Other NDCs under ANDA 215766
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 |
|---|---|---|---|---|
| famotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Camber Consumer Care Inc | 69230-326 |
| Famotidine | Famotidine 10 mg/10mg | TabletOral | Little Pharma, Inc. | 72559-038 |
| famotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-003 |
| famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-008 |
| Goodmeds Famotidine 20mg 500 countfamotidine 20mg | Famotidine 20 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-4047 |