What is NDC 11534-200?

11534-200 is the product NDC for Sulfasalazine, Sulfasalazine 500 mg/1 tablet, listed with the FDA by Sunrise Pharmaceutical, Inc.. It has 3 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 11534-200 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)11534-200Labeler and product segments. Claims need a package NDC.

Product NDC at billing width11534-0200Add 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
11534-200-01	1153402000111534020001	100 TABLET in 1 BOTTLE (11534-200-01)Marketed from Jul 15, 2025
11534-200-04	1153402000411534020004	500 TABLET in 1 BOTTLE (11534-200-04)Marketed from Jul 15, 2025
11534-200-07	1153402000711534020007	300 TABLET in 1 BOTTLE (11534-200-07)Marketed from Jul 15, 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
Route: Oral
Labeler: Sunrise Pharmaceutical, Inc.NDC labeler code 11534
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040349
Marketing start: Jul 15, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Aminosalicylic Acids (Chemical structure)
Identifiers: Product ID 11534-200_97b74888-4b28-4f9a-b5b9-64d23bc7e808SPL ID 97b74888-4b28-4f9a-b5b9-64d23bc7e808SPL set ID a54b31cc-205d-43d3-a850-acf4b41fbc37RxCUI 198232UNII 3XC8GUZ6CBUPC 0311534200072, 0311534200010, 0311534200041
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

N411534020001 followed by a unit qualifier and the quantity

Package 11534-0200-01. 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 Sep 15, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Sulfasalazine tablets are indicated: a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and b) for the prolongation of the remission period between acute attacks of ulcerative colitis

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 11534-200

What is NDC 11534-200?: 11534-200 is the product NDC for Sulfasalazine, Sulfasalazine 500 mg/1 tablet, listed with the FDA by Sunrise Pharmaceutical, Inc.. It has 3 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	Tablet, Delayed releaseOral	Sunrise Pharmaceutical, Inc.	11534-201	11534-0201-0111534-0201-07
Sulfasalazine	Sulfasalazine 500 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-261	16571-0261-0116571-0261-30
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