Prescription drug · ANDA
Budesonide NDC 47335-631
Budesonide .25 mg/2mL · Suspension · Respiratory (Inhalation) · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-631-49 | 47335063149 | 6 POUCH in 1 CARTON (47335-631-49) / 5 AMPULE in 1 POUCH (47335-631-48) / 2 mL in 1 AMPULEMarketed from May 1, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — .25 mg/2mL
- Dosage form
- Suspension
- Route
- Respiratory (Inhalation)
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211922
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 47335-631_c5265800-f7ea-4258-8555-5465104858a0SPL ID c5265800-f7ea-4258-8555-5465104858a0SPL set ID a39fbcfc-3ffd-44bd-b882-01f8e1844213RxCUI 252559, 349094, 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
N447335063149followed by a unit qualifier and the quantityPackage 47335-0631-49. 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 is an inhaled corticosteroid indicated for: Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age (1) Limitations of Use: Not indicated for the relief of acute bronchospasm (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 47335-631
- What is NDC 47335-631?
- 47335-631 is the product NDC for Budesonide, Budesonide .25 mg/2mL suspension, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Budesonide.
- What is the active ingredient?
- Budesonide.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. 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?
- 43 other product NDCs are listed under this name. See all Budesonide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Budesonide 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 | Budesonide .25 mg/2mL | SuspensionRespiratory (Inhalation) | American Health Packaging | 60687-889 | 60687-0889-83 |
| budesonide | Budesonide 3 mg/1 | Capsule, Coated pelletsOral | REMEDYREPACK INC. | 70518-4613 | 70518-4613-00 |
| Budesonide | Budesonide 32 ug/1 | Spray, MeteredNasal | Rugby Laboratories | 0536-1456 | 00536-1456-84 |
| Budesonide | Budesonide 32 ug/1 | Spray, MeteredNasal | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-703 | 49035-0703-01 |
| Budesonide | Budesonide 32 ug/1 | Spray, MeteredNasal | Walgreens | 0363-0048 | 00363-0048-01 |
| Budesonide | Budesonide 32 ug/1 | Spray, MeteredNasal | CVS Pharmacy | 69842-001 | 69842-0001-01 |
| Budesonide | Budesonide 3 mg/1 | Capsule, Delayed releaseOral | Amneal Pharmaceuticals of New York LLC | 53746-778 | 53746-0778-10 |
| Budesonide | Budesonide .25 mg/2mL | InhalantRespiratory (Inhalation) | Rising Pharma Holdings, Inc. | 64980-638 | 64980-0638-03 |
| Budesonide | Budesonide .5 mg/2mL | InhalantRespiratory (Inhalation) | Rising Pharma Holdings, Inc. | 64980-639 | 64980-0639-03 |
| budesonide | Budesonide 3 mg/1 | Capsule, Coated pelletsOral | Major Pharmaceuticals | 0904-7313 | 00904-7313-10 |
Other NDCs under ANDA 211922
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) | A-S Medication Solutions | 50090-6586 |
| Budesonide | Budesonide .25 mg/2mL | SuspensionRespiratory (Inhalation) | A-S Medication Solutions | 50090-6590 |
| Budesonide | Budesonide .25 mg/2mL | SuspensionRespiratory (Inhalation) | American Health Packaging | 60687-889 |
| Budesonide | Budesonide .5 mg/2mL | SuspensionRespiratory (Inhalation) | Sun Pharmaceutical Industries, Inc. | 47335-632 |
| Budesonide | Budesonide 1 mg/2mL | SuspensionRespiratory (Inhalation) | Sun Pharmaceutical Industries, Inc. | 47335-633 |