Budesonide NDC 0536-1112

NDC codes

FDA NDC Directory

Product NDC (as listed)0536-1112Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00536-1112Add 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
0536-1112-48	00536111248	1 BOTTLE, SPRAY in 1 CARTON (0536-1112-48) / 120 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Jul 27, 2016

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 32 ug/1
Dosage form: Spray, Metered
Route: Nasal
Labeler: Rugby Laboratories
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078949
Marketing start: Jul 27, 2016
Marketing end: Jun 30, 2027
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0536-1112_ce26c1bb-c50d-7731-6877-0b8a5fda98dfSPL ID ce26c1bb-c50d-7731-6877-0b8a5fda98dfSPL set ID 04eb9e98-1323-353f-3fd7-2d317dfac526RxCUI 1797929UNII 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. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400536111248 followed by a unit qualifier and the quantity

Package 00536-1112-48. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 078949

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

FDA NDC Directory listings under ANDA 078949
Product	Strength	Form · route	Labeler	Product NDC
Budesonide	Budesonide 32 ug/1	Spray, MeteredNasal	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	49035-703
Budesonide	Budesonide 32 ug/1	Spray, MeteredNasal	CVS Pharmacy	69842-001
Budesonide	Budesonide 32 ug/1	Spray, MeteredNasal	Walgreens	0363-0048
Budesonide	Budesonide 32 ug/1	Spray, MeteredNasal	Rugby Laboratories	0536-1456
Budesonide	Budesonide 32 ug/1	Spray, MeteredNasal	Apotex Corp.	60505-6129