What is NDC 63629-8294?

63629-8294 is the product NDC for Budesonide, Budesonide 3 mg/1 capsule, delayed release, 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 Budesonide?

43 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Budesonide NDC 63629-8294 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-8294Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-8294Add 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
63629-8294-1	63629829401	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-8294-1)Marketed from Feb 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): Budesonide
Generic name (nonproprietary): budesonide
Active ingredients: Budesonide — 3 mg/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 63629
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206200
Marketing start: Sep 15, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 63629-8294_a249352d-1d2d-4646-8a2b-81a2e37b7e86SPL ID a249352d-1d2d-4646-8a2b-81a2e37b7e86SPL set ID 4943ef5b-f48b-49d6-b419-467f71ef64e0RxCUI 1244214UNII Q3OKS62Q6X
Pharmacologic class: Corticosteroid

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

N463629829401 followed by a unit qualifier and the quantity

Package 63629-8294-01. 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 Oct 29, 2024.

Indications (excerpt from the label)

Budesonide delayed-release capsules are a corticosteroid indicated for: Treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon, in patients 8 years and older. (1.1) Maintenance of clinical remission of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3 months in adults. (1.2) 1.1 Treatment of Mild to Moderate Active Crohn’s Disease Budesonide delayed-release capsules are indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older. 1.2 Maintenance of Clinical Remission of Mild to Moderate Crohn’s Disease Budesonide…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-8294

What is NDC 63629-8294?: 63629-8294 is the product NDC for Budesonide, Budesonide 3 mg/1 capsule, delayed release, 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?: Budesonide.
What is the active ingredient?: Budesonide.
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 Budesonide?: 43 other product NDCs are listed under this name. See all Budesonide 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 Budesonide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Budesonide	Budesonide .25 mg/2mL	SuspensionRespiratory (Inhalation)	American Health Packaging	60687-889	60687-0889-83
budesonide	Budesonide 3 mg/1	Capsule, Coated pelletsOral	REMEDYREPACK INC.	70518-4613	70518-4613-00
Budesonide	Budesonide 32 ug/1	Spray, MeteredNasal	Rugby Laboratories	0536-1456	00536-1456-84
Budesonide	Budesonide 32 ug/1	Spray, MeteredNasal	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	49035-703	49035-0703-01
Budesonide	Budesonide 32 ug/1	Spray, MeteredNasal	Walgreens	0363-0048	00363-0048-01
Budesonide	Budesonide 32 ug/1	Spray, MeteredNasal	CVS Pharmacy	69842-001	69842-0001-01
Budesonide	Budesonide 3 mg/1	Capsule, Delayed releaseOral	Amneal Pharmaceuticals of New York LLC	53746-778	53746-0778-10
Budesonide	Budesonide .25 mg/2mL	InhalantRespiratory (Inhalation)	Rising Pharma Holdings, Inc.	64980-638	64980-0638-03
Budesonide	Budesonide .5 mg/2mL	InhalantRespiratory (Inhalation)	Rising Pharma Holdings, Inc.	64980-639	64980-0639-03
budesonide	Budesonide 3 mg/1	Capsule, Coated pelletsOral	Major Pharmaceuticals	0904-7313	00904-7313-10

All 44 Budesonide NDCs

Other NDCs under ANDA 206200

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

FDA NDC Directory listings under ANDA 206200
Product	Strength	Form · route	Labeler	Product NDC
Budesonide	Budesonide 3 mg/1	Capsule, Delayed releaseOral	Amneal Pharmaceuticals of New York LLC	53746-778
Budesonide	Budesonide 3 mg/1	Capsule, Delayed releaseOral	Amneal Pharmaceuticals LLC	65162-778