NDC codes

FDA NDC Directory
Product NDC (as listed)50742-278Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50742-0278Add 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
50742-278-015074202780150742027801100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50742-278-01)Marketed from Sep 26, 2022

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)
Diclofenac sodium
Generic name (nonproprietary)
diclofenac sodium
Active ingredients
Diclofenac sodium — 100 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Ingenus Pharmaceuticals, LLCNDC labeler code 50742
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216275
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers
Product ID 50742-278_37537219-52df-4924-8bae-4188c8eb922bSPL ID 37537219-52df-4924-8bae-4188c8eb922bSPL set ID 1a237198-ca24-4159-b570-b5a23c8e91b0RxCUI 855657UNII QTG126297Q

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

N450742027801 followed by a unit qualifier and the quantity

Package 50742-0278-01. 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)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diclofenac sodium extended-release tablets and other treatment options before deciding to use diclofenac sodium extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ; Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac sodium extended-release tablets are indicated: for relief of the signs and symptoms of osteoarthritis for relief of the signs and symptoms of rheumatoid arthritis

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50742-278

What is NDC 50742-278?
50742-278 is the product NDC for Diclofenac sodium, Diclofenac sodium 100 mg/1 tablet, film coated, listed with the FDA by Ingenus Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Diclofenac sodium.
What is the active ingredient?
Diclofenac sodium.
Who is the labeler?
Ingenus Pharmaceuticals, LLC, NDC labeler code 50742. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Diclofenac sodium?
241 other product NDCs are listed under this name. See all Diclofenac sodium 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 Diclofenac sodium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Diclofenac Sodiumdiclofenac sodium topical gel, 1%Diclofenac sodium 10 mg/gGelTopicalIPG Pharmaceuticals, inc.71085-08471085-0084-03
Diclofenac SodiumDiclofenac sodium 10 mg/gGelTopicalTarget Corporation11673-02811673-0028-1011673-0028-15
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralNorthwind Health Company, LLC82868-11482868-0114-30
Diclofenac SodiumDiclofenac sodium 10 mg/gGelTopicalPreferred Pharmaceuticals Inc.68788-413568788-4135-01
Diclofenac SodiumDiclofenac sodium 100 mg/1Tablet, Film coated, Extended releaseOralAurobindo Pharma Limited84386-10384386-0103-01
Diclofenac SodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralREMEDYREPACK INC.70518-469470518-4694-00
Diclofenac sodiumDiclofenac sodium 30 mg/gGelTopicalPreferred Pharmaceuticals Inc.68788-411868788-4118-01
Diclofenac SodiumDiclofenac sodium 10 mg/gGelTopicalPreferred Pharmaceuticals Inc.68788-433568788-4335-01
Diclofenac SodiumDiclofenac sodium 25 mg/1Tablet, Delayed releaseOralUmedica Laboratories USA Inc.60290-08260290-0082-01
Diclofenac SodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralUmedica Laboratories USA Inc.60290-08360290-0083-0160290-0083-0260290-0083-03+1 more

All 242 Diclofenac sodium NDCs

Other NDCs under ANDA 216275

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

FDA NDC Directory listings under ANDA 216275
ProductStrengthForm · routeLabelerProduct NDC
Diclofenac sodiumDiclofenac sodium 100 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-612
Diclofenac sodiumDiclofenac sodium 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4044
Diclofenac sodiumDiclofenac sodium 100 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-9665
Diclofenac sodiumDiclofenac sodium 100 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-598
Diclofenac sodiumDiclofenac sodium 100 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0414
Diclofenac sodiumDiclofenac sodium 100 mg/1Tablet, Film coatedOralSportpharm LLC85766-032

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