Over-the-counter drug · NDA
PEPCID AC Maximum Strength (Famotidine) NDC 16837-855
Famotidine 20 mg/1 · Tablet, Film coated · Oral · Kenvue Brands LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16837-855-02 | 1683708550216837085502 | 2 POUCH in 1 CARTON (16837-855-02) / 1 TABLET, FILM COATED in 1 POUCHMarketed from Jun 5, 2023 | |
| 16837-855-09 | 1683708550916837085509 | 1 BOTTLE, PLASTIC in 1 PACKAGE (16837-855-09) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Sep 1, 2003 | |
| 16837-855-12 | 1683708551216837085512 | 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Sep 1, 2003 | |
| 16837-855-13 | 1683708551316837085513 | 1 TABLET, FILM COATED in 1 POUCH (16837-855-13)Marketed from Sep 1, 2003 | |
| 16837-855-14 | 1683708551416837085514 | 5 BLISTER PACK in 1 CARTON (16837-855-14) / 5 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Sep 1, 2003 | |
| 16837-855-15 | 1683708551516837085515 | 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-15) / 35 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Sep 1, 2003 | |
| 16837-855-16 | 1683708551616837085516 | 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-16) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Sep 1, 2003 | |
| 16837-855-18 | 1683708551816837085518 | 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-18) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Sep 1, 2003 | |
| 16837-855-19 | 1683708551916837085519 | 1 BLISTER PACK in 1 CARTON (16837-855-19) / 8 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 27, 2015 | |
| 16837-855-20 | 1683708552016837085520 | 2 CARTON in 1 PACKAGE (16837-855-20) / 1 BOTTLE, PLASTIC in 1 CARTON / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Aug 22, 2014 | |
| 16837-855-24 | 1683708552416837085524 | 2500 POUCH in 1 CARTON (16837-855-24) / 1 TABLET, FILM COATED in 1 POUCHMarketed from Jun 5, 2023 | |
| 16837-855-50 | 1683708555016837085550 | 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Sep 1, 2003 | |
| 16837-855-52 | 1683708555216837085552 | 50 POUCH in 1 TRAY (16837-855-52) / 1 TABLET, FILM COATED in 1 POUCHMarketed from Sep 1, 2003 | |
| 16837-855-70 | 1683708557016837085570 | 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-70) / 70 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Sep 1, 2003 | |
| 16837-855-75 | 1683708557516837085575 | 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-75) / 75 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Sep 1, 2003 | |
| 16837-855-80 | 1683708558016837085580 | 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-80) / 80 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Sep 1, 2003 | |
| 16837-855-85 | 1683708558516837085585 | 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-85) / 85 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Sep 1, 2003 | |
| 16837-855-90 | 1683708559016837085590 | 125 TABLET, FILM COATED in 1 PACKAGE, COMBINATION (16837-855-90)Marketed from Mar 15, 2021 |
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 Maximum StrengthSuffix: Maximum Strength
- Generic name (nonproprietary)
- famotidine
- Active ingredients
- Famotidine — 20 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 16837-855_21af0de6-18c5-b8e8-e063-6394a90af51fSPL ID 21af0de6-18c5-b8e8-e063-6394a90af51fSPL set ID 2854047f-c5c4-43c3-8ef2-5c0a84a307f2RxCUI 104094, 310273UNII 5QZO15J2Z8UPC 0716837855255
- 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
N416837085502followed by a unit qualifier and the quantityPackage 16837-0855-02. 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 16837-855
- What is NDC 16837-855?
- 16837-855 is the product NDC for PEPCID AC Maximum Strength (famotidine), Famotidine 20 mg/1 tablet, film coated, listed with the FDA by Kenvue Brands LLC. It has 18 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- PEPCID AC Maximum 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 Maximum 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 Original Strengthfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Kenvue Brands LLC | 16837-872 |