Over-the-counter drug · NDA
Pepcid AC Original Strength (Famotidine) NDC 16837-872
Famotidine 10 mg/1 · Tablet, Film coated · Oral · Kenvue Brands LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16837-872-20 | 1683708722016837087220 | 3 BLISTER PACK in 1 CARTON (16837-872-20) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 21, 2011 | |
| 16837-872-22 | 1683708722216837087222 | 1 BOTTLE, PLASTIC in 1 CARTON (16837-872-22) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Jan 21, 2011 | |
| 16837-872-30 | 1683708723016837087230 | 3 BLISTER PACK in 1 CARTON (16837-872-30) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 1, 1995 | |
| 16837-872-90 | 1683708729016837087290 | 1 BOTTLE, PLASTIC in 1 CARTON (16837-872-90) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Oct 1, 1995 |
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)
- Pepcid AC Original StrengthSuffix: Original Strength
- Generic name (nonproprietary)
- famotidine
- Active ingredients
- Famotidine — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Kenvue Brands LLCNDC labeler code 16837
- 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 16837-872_4a227807-355e-b37d-e063-6394a90a7639SPL ID 4a227807-355e-b37d-e063-6394a90a7639SPL set ID 54f4086f-e443-4e7e-8c7e-94e152e1c256RxCUI 199047, 212072UNII 5QZO15J2Z8
- 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
N416837087220followed by a unit qualifier and the quantityPackage 16837-0872-20. 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.
About NDC 16837-872
- What is NDC 16837-872?
- 16837-872 is the product NDC for Pepcid AC Original Strength (famotidine), Famotidine 10 mg/1 tablet, film coated, listed with the FDA by Kenvue Brands LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pepcid AC Original Strength (Famotidine).
- What is the active ingredient?
- Famotidine.
- Who is the labeler?
- Kenvue Brands LLC, NDC labeler code 16837. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pepcid AC Original Strength?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
|---|---|---|---|---|
| Maximum Strength PEPCID AC Icy Cool Mintfamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Kenvue Brands LLC | 16837-889 |
| 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 |