What is NDC 53746-778?

53746-778 is the product NDC for Budesonide, Budesonide 3 mg/1 capsule, delayed release, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. 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 53746-778 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)53746-778Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53746-0778Add 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
53746-778-10	53746077810	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (53746-778-10)Marketed from May 22, 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): Budesonide
Generic name (nonproprietary): budesonide
Active ingredients: Budesonide — 3 mg/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLCNDC labeler code 53746
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206200
Marketing start: May 22, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 53746-778_6c4112fe-354a-472f-97ba-fa86d405b7f7SPL ID 6c4112fe-354a-472f-97ba-fa86d405b7f7SPL set ID 10336e42-0e9d-45c4-80bc-5149d5ec9e1cRxCUI 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

N453746077810 followed by a unit qualifier and the quantity

Package 53746-0778-10. 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 Jun 19, 2025.

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 Budeso…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53746-778

What is NDC 53746-778?: 53746-778 is the product NDC for Budesonide, Budesonide 3 mg/1 capsule, delayed release, listed with the FDA by Amneal Pharmaceuticals of New York LLC. 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?: Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. 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	Walgreens	0363-0048	00363-0048-01
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	CVS Pharmacy	69842-001	69842-0001-01
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
Budesonide	Budesonide .5 mg/2mL	SuspensionRespiratory (Inhalation)	Aurobindo Pharma Limited	59651-585	59651-0585-30

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	Bryant Ranch Prepack	63629-8294
Budesonide	Budesonide 3 mg/1	Capsule, Delayed releaseOral	Amneal Pharmaceuticals LLC	65162-778