Prescription drug · ANDA
budesonide NDC 70518-4613
Budesonide 3 mg/1 · Capsule, Coated pellets · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4613-0 | 7051846130070518461300 | 50 POUCH in 1 BOX (70518-4613-0) / 1 CAPSULE, COATED PELLETS in 1 POUCH (70518-4613-1)Marketed from Apr 23, 2026 |
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
- Generic name (nonproprietary)
- budesonide
- Active ingredients
- Budesonide — 3 mg/1
- Dosage form
- Capsule, Coated pellets
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- 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 70518-4613_5252be96-0238-7516-e063-6294a90a2329SPL ID 5252be96-0238-7516-e063-6294a90a2329SPL set ID 5e39c491-2793-410e-b77f-8b3cbe9b6231RxCUI 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
N470518461300followed by a unit qualifier and the quantityPackage 70518-4613-00. 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 Budesoni…
Excerpt only. Read the full label for complete information.
About NDC 70518-4613
- What is NDC 70518-4613?
- 70518-4613 is the product NDC for budesonide, Budesonide 3 mg/1 capsule, coated pellets, listed with the FDA by REMEDYREPACK 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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 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 3 mg/1 | Capsule, Coated pelletsOral | Major Pharmaceuticals | 0904-7313 | 00904-7313-10 |
| 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 | Major Pharmaceuticals | 0904-7313 |
| 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 | Zydus Lifesciences Limited | 70771-1075 |