NDC codes

FDA NDC Directory
Product NDC (as listed)59762-0104Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59762-0104Add 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
59762-0104-559762010405597620104051 BOTTLE in 1 CARTON (59762-0104-5) / 100 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Mar 23, 2020
59762-0104-659762010406597620104061 BOTTLE in 1 CARTON (59762-0104-6) / 300 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Apr 6, 2020

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)
Sulfasalazine
Generic name (nonproprietary)
sulfasalazine
Active ingredients
Sulfasalazine — 500 mg/1
Dosage form
Tablet, Delayed release
Route
Oral
Labeler
Mylan Pharmaceuticals Inc.NDC labeler code 59762
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 007073
Marketing start
Listing expires
Other FDA classes
Aminosalicylic Acids (Chemical structure)
Identifiers
Product ID 59762-0104_0e53b1e5-3efe-4e5a-8d20-108f96490393SPL ID 0e53b1e5-3efe-4e5a-8d20-108f96490393SPL set ID 257cee60-b68f-4c2b-b57d-8e4d73d17e09RxCUI 313142UNII 3XC8GUZ6CBUPC 0359762010414
Pharmacologic class
Aminosalicylate

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

N459762010405 followed by a unit qualifier and the quantity

Package 59762-0104-05. 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)

INDICATIONS AND USAGE Sulfasalazine delayed release tablets are indicated: a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; b) for the prolongation of the remission period between acute attacks of ulcerative colitis; c) in the treatment of patients with rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs (e.g., an insufficient therapeutic response to, or intolerance of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs); and d) in the treatment of pediatric patients with polyarticular-course 1 juvenile rheumatoid arthritis who have…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59762-0104

What is NDC 59762-0104?
59762-0104 is the product NDC for Sulfasalazine, Sulfasalazine 500 mg/1 tablet, delayed release, 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?
Sulfasalazine.
What is the active ingredient?
Sulfasalazine.
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 Sulfasalazine?
11 other product NDCs are listed under this name. See all Sulfasalazine 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 Sulfasalazine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
SulfasalazineSulfasalazine 500 mg/1Tablet, Delayed releaseOralSunrise Pharmaceutical, Inc.11534-20111534-0201-0111534-0201-07
SulfasalazineSulfasalazine 500 mg/1TabletOralRising Pharma Holdings, Inc.16571-26116571-0261-0116571-0261-30
SulfasalazineSulfasalazine 500 mg/1TabletOralSunrise Pharmaceutical, Inc.11534-20011534-0200-0111534-0200-0411534-0200-07
SulfasalazineSulfasalazine 500 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0093-323400093-3234-0100093-3234-0500093-3234-10
SulfasalazineSulfasalazine 500 mg/1TabletOralBryant Ranch Prepack63629-971563629-9715-01
SulfasalazineSulfasalazine 500 mg/1TabletOralREMEDYREPACK INC.70518-182970518-1829-03
SulfasalazineSulfasalazine 500 mg/1TabletOralA-S Medication Solutions50090-008650090-0086-04
SulfasalazineSulfasalazine 500 mg/1TabletOralA-S Medication Solutions50090-693650090-6936-00
SulfasalazineSulfasalazine 500 mg/1TabletOralMylan Pharmaceuticals Inc.59762-500059762-5000-0559762-5000-06
SulfasalazineSulfasalazine 500 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-70671610-0706-7071610-0706-80

All 12 Sulfasalazine NDCs

Other NDCs under NDA 007073

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

FDA NDC Directory listings under NDA 007073
ProductStrengthForm · routeLabelerProduct NDC
AzulfidinesulfasalazineSulfasalazine 500 mg/1TabletOralPfizer Laboratories Div Pfizer Inc0013-0101
Azulfidine EN-tabssulfasalazineSulfasalazine 500 mg/1Tablet, Delayed releaseOralPfizer Laboratories Div Pfizer Inc0013-0102
SulfasalazineSulfasalazine 500 mg/1TabletOralA-S Medication Solutions50090-0086
SulfasalazineSulfasalazine 500 mg/1TabletOralA-S Medication Solutions50090-6936
SulfasalazineSulfasalazine 500 mg/1TabletOralMylan Pharmaceuticals Inc.59762-5000
SulfasalazineSulfasalazine 500 mg/1TabletOralREMEDYREPACK INC.70518-1829
SulfasalazineSulfasalazine 500 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-706

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