Prescription drug · ANDA
Budesonide NDC 0093-6816
Budesonide .5 mg/2mL · Suspension · Respiratory (Inhalation) · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-6816-55 | 00093681655 | 30 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
N400093681655followed by a unit qualifier and the quantityPackage 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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Budesonide | Budesonide .5 mg/2mL | SuspensionRespiratory (Inhalation) | Cardinal Health 107, LLC | 55154-4849 |
| Budesonide | Budesonide .25 mg/2mL | SuspensionRespiratory (Inhalation) | A-S Medication Solutions | 50090-1467 |
| Budesonide | Budesonide .25 mg/2mL | SuspensionRespiratory (Inhalation) | Teva Pharmaceuticals USA, Inc. | 0093-6815 |
| Budesonide | Budesonide .25 mg/2mL | SuspensionRespiratory (Inhalation) | Teva Pharmaceuticals USA, Inc. | 0093-6815 |