NDC codes

FDA NDC Directory
Product NDC (as listed)0093-6816Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00093-6816Add 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 NDC11-digit (billing)PackageCopy
0093-6816-550009368165530 POUCH in 1 CARTON (0093-6816-55) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 11, 2019

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 — .5 mg/2mL
Dosage form
Suspension
Route
Respiratory (Inhalation)
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077519
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 0093-6816_551a929a-3517-4e58-9df6-f9bfb0f2f3beSPL ID 551a929a-3517-4e58-9df6-f9bfb0f2f3beSPL set ID 4f126a29-38f7-4c4c-8978-37e72b289902RxCUI 349094, 351109UNII Q3OKS62Q6XUPC 0300936816554, 0300936815557
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N400093681655 followed by a unit qualifier and the quantity

Package 00093-6816-55. 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 077519

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

FDA NDC Directory listings under ANDA 077519
ProductStrengthForm · routeLabelerProduct NDC
BudesonideBudesonide .5 mg/2mLSuspensionRespiratory (Inhalation)Cardinal Health 107, LLC55154-4849
BudesonideBudesonide .25 mg/2mLSuspensionRespiratory (Inhalation)A-S Medication Solutions50090-1467
BudesonideBudesonide .25 mg/2mLSuspensionRespiratory (Inhalation)Teva Pharmaceuticals USA, Inc.0093-6815
BudesonideBudesonide .25 mg/2mLSuspensionRespiratory (Inhalation)Teva Pharmaceuticals USA, Inc.0093-6815

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in