NDC codes

FDA NDC Directory
Product NDC (as listed)67877-626Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67877-0626Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
67877-626-0167877062601100 TABLET, FILM COATED in 1 BOTTLE (67877-626-01)Marketed from Aug 4, 2021
67877-626-0567877062605500 TABLET, FILM COATED in 1 BOTTLE (67877-626-05)Marketed from Aug 4, 2021
67877-626-06678770626066 BLISTER PACK in 1 CARTON (67877-626-06) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Aug 4, 2021
67877-626-906787706269090 TABLET, FILM COATED in 1 BOTTLE (67877-626-90)Marketed from Aug 4, 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)
Ibuprofen and famotidine
Generic name (nonproprietary)
ibuprofen and famotidine
Active ingredients
Ibuprofen — 800 mg/1Famotidine — 26.6 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211890
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H2 Receptor Antagonists (Mechanism)
Identifiers
Product ID 67877-626_a3b31470-cb68-49d5-8fc4-3ae38b284701SPL ID a3b31470-cb68-49d5-8fc4-3ae38b284701SPL set ID 4493d4cd-ca8e-4b0a-9b65-b75e55bf8b9eRxCUI 1100066UNII WK2XYI10QM, 5QZO15J2Z8

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

N467877062601 followed by a unit qualifier and the quantity

Package 67877-0626-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Ibuprofen and famotidine tablet, a combination of the NSAID ibuprofen and the histamine H 2 -receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months [see Clinical Studies ( 14 ), Use in Specific Populations ( 8.5 )] . Ibuprofen and famotidine tablet, …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211890

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 211890
ProductStrengthForm · routeLabelerProduct NDC
Ibuprofen and famotidineIbuprofen 800 mg/1; Famotidine 26.6 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-8891
Ibuprofen and famotidineIbuprofen 800 mg/1; Famotidine 26.6 mg/1Tablet, Film coatedOralPHOENIX RX LLC85509-1010
Ibuprofen and famotidineIbuprofen 800 mg/1; Famotidine 26.6 mg/1Tablet, Film coatedOralPHOENIX RX LLC85509-1626
Ibuprofen and famotidineIbuprofen 800 mg/1; Famotidine 26.6 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8897
Ibuprofen and famotidineIbuprofen 800 mg/1; Famotidine 26.6 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4580
Ibuprofen and famotidineIbuprofen 800 mg/1; Famotidine 26.6 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-891
Ibuprofen and famotidineIbuprofen 800 mg/1; Famotidine 26.6 mg/1Tablet, Film coatedOralDoc Rx69306-266
Ibuprofen and famotidineIbuprofen 800 mg/1; Famotidine 26.6 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0422
Ibuprofen FamotidineIbuprofen 800 mg/1; Famotidine 26.6 mg/1Tablet, Film coatedOralDirect_Rx72189-641

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