What is NDC 63629-9715?

63629-9715 is the product NDC for Sulfasalazine, Sulfasalazine 500 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 63629. 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 63629-9715 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-9715Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-9715Add 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
63629-9715-1	6362997150163629971501	90 TABLET in 1 BOTTLE, PLASTIC (63629-9715-1)Marketed from Jun 22, 2023

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
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 63629
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 085828
Marketing start: Dec 15, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Aminosalicylic Acids (Chemical structure)
Identifiers: Product ID 63629-9715_00104d3b-3b62-49fb-8a04-26ec7c24efccSPL ID 00104d3b-3b62-49fb-8a04-26ec7c24efccSPL set ID 618c5324-d0a6-4d00-9b12-0de88a71c180RxCUI 198232UNII 3XC8GUZ6CB
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

N463629971501 followed by a unit qualifier and the quantity

Package 63629-9715-01. 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 Apr 4, 2024.

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 63629-9715

What is NDC 63629-9715?: 63629-9715 is the product NDC for Sulfasalazine, Sulfasalazine 500 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, 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?: Bryant Ranch Prepack, NDC labeler code 63629. 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	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	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

Other NDCs under ANDA 085828

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

FDA NDC Directory listings under ANDA 085828
Product	Strength	Form · route	Labeler	Product NDC
Sulfasalazine	Sulfasalazine 500 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	0093-3234