NDC codes

FDA NDC Directory
Product NDC (as listed)76420-891Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76420-0891Add 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
76420-891-017642008910176420089101100 TABLET, FILM COATED in 1 BOTTLE (76420-891-01)Marketed from Jan 2, 2025
76420-891-057642008910576420089105500 TABLET, FILM COATED in 1 BOTTLE (76420-891-05)Marketed from Jan 2, 2025
76420-891-0676420089106764200891066 BLISTER PACK in 1 CARTON (76420-891-06) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 2, 2025
76420-891-30764200891307642008913030 TABLET, FILM COATED in 1 BOTTLE (76420-891-30)Marketed from Jan 2, 2025
76420-891-60764200891607642008916060 TABLET, FILM COATED in 1 BOTTLE (76420-891-60)Marketed from Jan 2, 2025
76420-891-90764200891907642008919090 TABLET, FILM COATED in 1 BOTTLE (76420-891-90)Marketed from Jan 2, 2025

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
Labeler
Asclemed USA, Inc.NDC labeler code 76420
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 76420-891_2abbd7c9-640f-d0cb-e063-6294a90a23f0SPL ID 2abbd7c9-640f-d0cb-e063-6294a90a23f0SPL set ID 41123df3-97ac-4c4f-9a89-f76ec03898bbRxCUI 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

N476420089101 followed by a unit qualifier and the quantity

Package 76420-0891-01. 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)

About NDC 76420-891

What is NDC 76420-891?
76420-891 is the product NDC for Ibuprofen and famotidine, Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 tablet, film coated, listed with the FDA by Asclemed USA, Inc.. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ibuprofen and famotidine.
What is the active ingredient?
Ibuprofen, Famotidine.
Who is the labeler?
Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ibuprofen and famotidine?
18 other product NDCs are listed under this name. See all Ibuprofen and famotidine NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Ibuprofen and famotidine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Ibuprofen and FamotidineIbuprofen 800 mg/1; Famotidine 26.6 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-058780425-0587-0180425-0587-0280425-0587-03
Ibuprofen and famotidineIbuprofen 800 mg/1; Famotidine 26.6 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-458070518-4580-00
Ibuprofen and famotidineIbuprofen 800 mg/1; Famotidine 26.6 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-889768788-8897-09
Ibuprofen and famotidineIbuprofen 800 mg/1; Famotidine 26.6 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-90859651-0908-90
Ibuprofen and FamotidineIbuprofen 800 mg/1; Famotidine 26.6 mg/1TabletOralZydus Lifesciences Limited70771-192470771-1924-09
Ibuprofen and FamotidineIbuprofen 800 mg/1; Famotidine 26.6 mg/1TabletOralViona Pharmaceuticals Inc72578-21472578-0214-16
Ibuprofen and famotidineIbuprofen 800 mg/1; Famotidine 26.6 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-042280425-0422-0180425-0422-0280425-0422-03
Ibuprofen And FamotidineIbuprofen 800 mg/1; Famotidine 26.6 mg/1TabletOralAdvanced Rx Pharmacy of Tennessee, LLC80425-038480425-0384-0180425-0384-0280425-0384-03
Ibuprofen and famotidineIbuprofen 800 mg/1; Famotidine 26.6 mg/1TabletOralPar Health USA, LLC49884-36649884-0366-09
Ibuprofen and famotidineIbuprofen 800 mg/1; Famotidine 26.6 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-048380425-0483-0180425-0483-0280425-0483-03

All 19 Ibuprofen and famotidine NDCs

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 coatedOralAscend Laboratories, LLC67877-626
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 coatedOralDoc Rx69306-266
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 coatedOralAdvanced Rx of Tennessee, LLC80425-0422
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 FamotidineIbuprofen 800 mg/1; Famotidine 26.6 mg/1Tablet, Film coatedOralDirect_Rx72189-641

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