What is NDC 11534-201?

11534-201 is the product NDC for Sulfasalazine, Sulfasalazine 500 mg/1 tablet, delayed release, listed with the FDA by Sunrise Pharmaceutical, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Sunrise Pharmaceutical, Inc., NDC labeler code 11534. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sulfasalazine NDC 11534-201 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)11534-201Labeler and product segments. Claims need a package NDC.

Product NDC at billing width11534-0201Add 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 NDC	11-digit (billing)	Package	Copy
11534-201-01	1153402010111534020101	100 TABLET, DELAYED RELEASE in 1 BOTTLE (11534-201-01)Marketed from Dec 11, 2025
11534-201-07	1153402010711534020107	300 TABLET, DELAYED RELEASE in 1 BOTTLE (11534-201-07)Marketed from Dec 11, 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): Sulfasalazine
Generic name (nonproprietary): sulfasalazine
Active ingredients: Sulfasalazine — 500 mg/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: Sunrise Pharmaceutical, Inc.NDC labeler code 11534
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075339
Marketing start: Dec 11, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Aminosalicylic Acids (Chemical structure)
Identifiers: Product ID 11534-201_86d69175-60ab-4573-9c76-b995fc3a7802SPL ID 86d69175-60ab-4573-9c76-b995fc3a7802SPL set ID d596ac59-b643-4181-80ba-f2db1cc3459cRxCUI 313142UNII 3XC8GUZ6CBUPC 0311534201017, 0311534201079
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

N411534020101 followed by a unit qualifier and the quantity

Package 11534-0201-01. 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 Dec 11, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE SULFASALAZINE DELAYED RELEASE Tablets, USP 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); andd)in the treatment of pediatric patients with polyarticular-course 1 juvenile rheumatoid arthritis who have r…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 11534-201

What is NDC 11534-201?: 11534-201 is the product NDC for Sulfasalazine, Sulfasalazine 500 mg/1 tablet, delayed release, listed with the FDA by Sunrise Pharmaceutical, 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?: Sunrise Pharmaceutical, Inc., NDC labeler code 11534. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sulfasalazine	Sulfasalazine 500 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-261	16571-0261-0116571-0261-30
Sulfasalazine	Sulfasalazine 500 mg/1	TabletOral	Sunrise Pharmaceutical, Inc.	11534-200	11534-0200-0111534-0200-0411534-0200-07
Sulfasalazine	Sulfasalazine 500 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	0093-3234	00093-3234-0100093-3234-0500093-3234-10
Sulfasalazine	Sulfasalazine 500 mg/1	TabletOral	Bryant Ranch Prepack	63629-9715	63629-9715-01
Sulfasalazine	Sulfasalazine 500 mg/1	TabletOral	REMEDYREPACK INC.	70518-1829	70518-1829-03
Sulfasalazine	Sulfasalazine 500 mg/1	Tablet, Delayed releaseOral	Mylan Pharmaceuticals Inc.	59762-0104	59762-0104-0559762-0104-06
Sulfasalazine	Sulfasalazine 500 mg/1	TabletOral	A-S Medication Solutions	50090-0086	50090-0086-04
Sulfasalazine	Sulfasalazine 500 mg/1	TabletOral	A-S Medication Solutions	50090-6936	50090-6936-00
Sulfasalazine	Sulfasalazine 500 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	59762-5000	59762-5000-0559762-5000-06
Sulfasalazine	Sulfasalazine 500 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-706	71610-0706-7071610-0706-80

All 12 Sulfasalazine NDCs