NDC codes

FDA NDC Directory
Product NDC (as listed)59762-0028Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59762-0028Add 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
59762-0028-1597620028015976200280160 TABLET, FILM COATED in 1 BOTTLE (59762-0028-1)Marketed from Nov 1, 2012
59762-0028-2597620028025976200280290 TABLET, FILM COATED in 1 BOTTLE (59762-0028-2)Marketed from Nov 1, 2012

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 and Misoprostol
Generic name (nonproprietary)
diclofenac sodium and misoprostol
Active ingredients
Diclofenac sodium — 50 mg/1Misoprostol — 200 ug/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Mylan Pharmaceuticals Inc.NDC labeler code 59762
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 020607
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)Synthetic (Chemical structure)
Identifiers
Product ID 59762-0028_354b9b31-a5f4-4f05-b476-2759945ed43eSPL ID 354b9b31-a5f4-4f05-b476-2759945ed43eSPL set ID a7701e8c-4e16-4165-8b83-de2c08d5ded3RxCUI 857706, 1359105UNII QTG126297Q, 0E43V0BB57UPC 0359762002914, 0359762002815
Pharmacologic class
Nonsteroidal Anti-inflammatory Drug; Prostaglandin E1 Analog

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

N459762002801 followed by a unit qualifier and the quantity

Package 59762-0028-01. 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)

Diclofenac sodium/misoprostol is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.3) ] . Diclofenac sodium/misoprostol is a combination of diclofenac sodium, a non‑steroidal anti‑inflammatory drug, and misoprostol, a prostaglandin-1 (PGE1) analog, indicated for the treatment of signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID‑ind…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59762-0028

What is NDC 59762-0028?
59762-0028 is the product NDC for Diclofenac sodium and Misoprostol, Diclofenac sodium 50 mg/1; Misoprostol 200 ug/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Diclofenac sodium and Misoprostol.
What is the active ingredient?
Diclofenac sodium, Misoprostol.
Who is the labeler?
Mylan Pharmaceuticals Inc., NDC labeler code 59762. 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 and Misoprostol?
10 other product NDCs are listed under this name. See all Diclofenac sodium and Misoprostol 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 and Misoprostol NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Diclofenac Sodium and MisoprostolDiclofenac sodium 50 mg/1; Misoprostol 200 ug/1Tablet, Delayed releaseOralAmneal Pharmaceuticals LLC65162-43665162-0436-0365162-0436-0665162-0436-09+1 more
Diclofenac Sodium and MisoprostolDiclofenac sodium 75 mg/1; Misoprostol 200 ug/1Tablet, Delayed releaseOralAmneal Pharmaceuticals LLC65162-43865162-0438-0365162-0438-0665162-0438-10
Diclofenac Sodium and MisoprostolDiclofenac sodium 75 mg/1; Misoprostol 200 ug/1Tablet, Delayed releaseOralBryant Ranch Prepack71335-118371335-1183-0171335-1183-0271335-1183-03+2 more
Diclofenac Sodium and MisoprostolDiclofenac sodium 50 mg/1; Misoprostol 200 ug/1Tablet, Delayed releaseOralBluePoint Laboratories68001-23168001-0231-06
Diclofenac Sodium and MisoprostolDiclofenac sodium 75 mg/1; Misoprostol 200 ug/1Tablet, Delayed releaseOralBluePoint Laboratories68001-23268001-0232-06
Diclofenac Sodium and MisoprostolDiclofenac sodium 50 mg/1; Misoprostol 200 ug/1Tablet, Delayed releaseOralAvKARE42291-23242291-0232-60
Diclofenac Sodium and MisoprostolDiclofenac sodium 75 mg/1; Misoprostol 200 ug/1Tablet, Delayed releaseOralAvKARE42291-23342291-0233-60
Diclofenac Sodium and MisoprostolDiclofenac sodium 50 mg/1; Misoprostol 200 ug/1Tablet, Delayed releaseOralActavis Pharma, Inc.0591-039700591-0397-1900591-0397-60
Diclofenac Sodium and MisoprostolDiclofenac sodium 75 mg/1; Misoprostol 200 ug/1Tablet, Delayed releaseOralActavis Pharma, Inc.0591-039800591-0398-60
Diclofenac sodium and MisoprostolDiclofenac sodium 75 mg/1; Misoprostol 200 ug/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.59762-002959762-0029-01

Other NDCs under NDA 020607

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

FDA NDC Directory listings under NDA 020607
ProductStrengthForm · routeLabelerProduct NDC
Arthrotecdiclofenac sodium and misoprostolDiclofenac sodium 50 mg/1; Misoprostol 200 ug/1Tablet, Film coatedOralPfizer Laboratories Div Pfizer Inc0025-1411
Arthrotecdiclofenac sodium and misoprostolDiclofenac sodium 75 mg/1; Misoprostol 200 ug/1Tablet, Film coatedOralPfizer Laboratories Div Pfizer Inc0025-1421
Diclofenac sodium and MisoprostolDiclofenac sodium 75 mg/1; Misoprostol 200 ug/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.59762-0029
Diclofenac sodium and Misoprostol DRdiclofenac sodium and misoprostolDiclofenac sodium 75 mg/1; Misoprostol 200 ug/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0272

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