Over-the-counter drug · NDA
Maximum Strength PEPCID AC Icy Cool Mint NDC 16837-889
famotidine · Famotidine 20 mg/1 · Tablet, Film coated · Oral · Kenvue Brands LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16837-889-20 | 16837088920 | 1 BOTTLE in 1 CARTON (16837-889-20) / 20 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 11, 2024 | |
| 16837-889-40 | 16837088940 | 1 BOTTLE in 1 CARTON (16837-889-40) / 40 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 11, 2024 |
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)
- Maximum Strength PEPCID AC Icy Cool MintSuffix: Icy Cool Mint
- Generic name (nonproprietary)
- famotidine
- Active ingredients
- Famotidine — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Kenvue Brands LLC
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020325
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 16837-889_21af4ff4-5892-565e-e063-6394a90aa728SPL ID 21af4ff4-5892-565e-e063-6394a90aa728SPL set ID 0f343092-4fc7-1fff-e063-6294a90aba6eRxCUI 104094, 310273UNII 5QZO15J2Z8UPC 0716837879404
- 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
N416837088920followed by a unit qualifier and the quantityPackage 16837-0889-20. 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.
Other NDCs under NDA 020325
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 |
|---|---|---|---|---|
| Pepcid ACfamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Lil' Drug Store Products, Inc. | 66715-9748 |
| PEPCID AC Maximum Strengthfamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Kenvue Brands LLC | 16837-855 |
| Pepcid AC Original Strengthfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Kenvue Brands LLC | 16837-872 |