Prescription drug · ANDA
Budesonide Inhalation (Budesonide) NDC 0115-1689
Budesonide .5 mg/2mL · Suspension · Respiratory (Inhalation) · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0115-1689-74 | 0011516897400115168974 | 6 POUCH in 1 CARTON (0115-1689-74) / 5 VIAL in 1 POUCH (0115-1689-76) / 2 mL in 1 VIALMarketed from Aug 4, 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 Inhalation
- Generic name (nonproprietary)
- budesonide
- Active ingredients
- Budesonide — .5 mg/2mL
- Dosage form
- Suspension
- Route
- Respiratory (Inhalation)
- Labeler
- Amneal Pharmaceuticals of New York LLCNDC labeler code 0115
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078404
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0115-1689_dbb6c949-66b1-4f60-ab96-442dd8b4ea19SPL ID dbb6c949-66b1-4f60-ab96-442dd8b4ea19SPL set ID e8ef9489-83a2-4817-b21c-ea3fecd8c8ddRxCUI 349094, 351109UNII Q3OKS62Q6XUPC 0301151687745
- 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
N400115168974followed by a unit qualifier and the quantityPackage 00115-1689-74. 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 .
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. ( 1.1 ) Limitations of Use: Not indicated for the relief of acute bronchospasm. ( 1.1 ) 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.
About NDC 0115-1689
- What is NDC 0115-1689?
- 0115-1689 is the product NDC for Budesonide Inhalation (budesonide), Budesonide .5 mg/2mL suspension, 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 Inhalation (Budesonide).
- What is the active ingredient?
- Budesonide.
- Who is the labeler?
- Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. 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 Inhalation?
- 6 other product NDCs are listed under this name. See all Budesonide Inhalation NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Budesonide Inhalation products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| budesonide inhalation | Budesonide .5 mg/2mL | SuspensionRespiratory (Inhalation) | Preferred Pharmaceuticals, Inc. | 68788-8503 | 68788-8503-03 |
| Budesonide Inhalationbudesonide | Budesonide .25 mg/2mL | SuspensionRespiratory (Inhalation) | Preferred Pharmaceuticals Inc. | 68788-8429 | 68788-8429-03 |
| Budesonide Inhalation | Budesonide .5 mg/2mL | SuspensionRespiratory (Inhalation) | American Health Packaging | 60687-524 | 60687-0524-83 |
| budesonide inhalation | Budesonide .5 mg/2mL | SuspensionRespiratory (Inhalation) | A-S Medication Solutions | 50090-7126 | 50090-7126-00 |
| budesonide inhalation | Budesonide .5 mg/2mL | SuspensionRespiratory (Inhalation) | Lupin Pharmaceuticals, Inc. | 68180-984 | 68180-0984-30 |
| Budesonide Inhalationbudesonide | Budesonide .25 mg/2mL | SuspensionRespiratory (Inhalation) | Amneal Pharmaceuticals of New York LLC | 0115-1687 | 00115-1687-74 |
Other NDCs under ANDA 078404
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 Inhalationbudesonide | Budesonide .25 mg/2mL | SuspensionRespiratory (Inhalation) | Amneal Pharmaceuticals of New York LLC | 0115-1687 |
| Budesonide Inhalationbudesonide | Budesonide .25 mg/2mL | SuspensionRespiratory (Inhalation) | Preferred Pharmaceuticals Inc. | 68788-8429 |