Prescription drug · ANDA
budesonide inhalation NDC 68788-8503
Budesonide .5 mg/2mL · Suspension · Respiratory (Inhalation) · Preferred Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8503-3 | 68788850303 | 6 POUCH in 1 CARTON (68788-8503-3) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULEMarketed from Aug 9, 2023 |
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 inhalation
- Generic name (nonproprietary)
- budesonide inhalation
- 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 210897
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 68788-8503_3b3a9e87-3f6a-4168-a2bc-04feee0ae479SPL ID 3b3a9e87-3f6a-4168-a2bc-04feee0ae479SPL set ID dd74e446-7c1b-4f02-9c73-ba716572ee77RxCUI 351109UNII 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 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
N468788850303followed by a unit qualifier and the quantityPackage 68788-8503-03. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Budesonide inhalation suspension is an inhaled corticosteroid indicated for: • Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age () Limitations of Use: Not indicated for the relief of acute bronchospasm () 1.1 Maintenance Treatment of Asthma Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Limitations of Use: • Budesonide inhalation suspension is NOT indicated for the relief of acute bronchospasm.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210897
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 Inhalation | Budesonide .5 mg/2mL | SuspensionRespiratory (Inhalation) | American Health Packaging | 60687-524 |
| budesonide inhalation | Budesonide .5 mg/2mL | SuspensionRespiratory (Inhalation) | A-S Medication Solutions | 50090-7126 |
| budesonide inhalation | Budesonide .5 mg/2mL | SuspensionRespiratory (Inhalation) | Lupin Pharmaceuticals, Inc. | 68180-984 |