Prescription drug · ANDA
budesonide NDC 0904-7313
Budesonide 3 mg/1 · Capsule, Coated pellets · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7313-10 | 0090473131000904731310 | 20 BLISTER PACK in 1 CARTON (0904-7313-10) / 1 CAPSULE, COATED PELLETS in 1 BLISTER PACKMarketed from Sep 3, 2024 |
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 — 3 mg/1
- Dosage form
- Capsule, Coated pellets
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206134
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0904-7313_cb9e8049-c3d3-466e-bf9c-3c5032030f4eSPL ID cb9e8049-c3d3-466e-bf9c-3c5032030f4eSPL set ID e7aca8d1-159e-4aac-b92d-3a69a8edceecRxCUI 1244214UNII 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400904731310followed by a unit qualifier and the quantityPackage 00904-7313-10. 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 delayed-release capsules are corticosteroid indicated for: • Treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon, in patients 8 years and older. ( 1.1 ) • Maintenance of clinical remission of mild to moderate Crohn's disease involving the ileum and/or the ascending colon for up to 3 months in adults. ( 1.2 ) 1.1 Treatment of Mild to Moderate Active Crohn’s Disease Budesonide delayed-release capsules are indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older. 1.2 Maintenance of Clinical Remission of Mild to Moderate Crohn’s Disease Bude…
Excerpt only. Read the full label for complete information.
About NDC 0904-7313
- What is NDC 0904-7313?
- 0904-7313 is the product NDC for budesonide, Budesonide 3 mg/1 capsule, coated pellets, listed with the FDA by Major Pharmaceuticals. 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?
- Major Pharmaceuticals, NDC labeler code 0904. 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?
- 41 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 | Walgreens | 0363-0048 | 00363-0048-01 |
| 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 | 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 .5 mg/2mL | SuspensionRespiratory (Inhalation) | Aurobindo Pharma Limited | 59651-585 | 59651-0585-30 |
Other NDCs under ANDA 206134
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 3 mg/1 | Capsule, Coated pelletsOral | Northstar Rx LLC. | 16714-829 |
| Budesonide | Budesonide 3 mg/1 | Capsule, Coated pelletsOral | American Health Packaging | 60687-596 |
| budesonide | Budesonide 3 mg/1 | Capsule, Coated pelletsOral | Zydus Pharmaceuticals USA Inc. | 68382-720 |
| budesonide | Budesonide 3 mg/1 | Capsule, Coated pelletsOral | REMEDYREPACK INC. | 70518-4613 |
| budesonide | Budesonide 3 mg/1 | Capsule, Coated pelletsOral | Zydus Lifesciences Limited | 70771-1075 |