Prescription drug · NDA
Uceris (Budesonide) NDC 68012-309
Budesonide 9 mg/1 · Tablet, Extended release · Oral · Santarus Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68012-309-01 | 6801203090168012030901 | 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68012-309-01)Marketed from Jan 14, 2013 | |
| 68012-309-02 | 6801203090268012030902 | 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68012-309-02)Marketed from Jan 14, 2013 | |
| 68012-309-30 | 6801203093068012030930 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68012-309-30)Marketed from Jan 14, 2013 |
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)
- Uceris
- Generic name (nonproprietary)
- budesonide
- Active ingredients
- Budesonide — 9 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Santarus Inc.NDC labeler code 68012
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203634
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 68012-309_250346dc-e6de-b148-e063-6394a90a1ca3SPL ID 250346dc-e6de-b148-e063-6394a90a1ca3SPL set ID 92cbb190-8851-46ed-bfe0-166ca62ef2e9RxCUI 1366550, 1366556UNII 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
N468012030901followed by a unit qualifier and the quantityPackage 68012-0309-01. 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)
UCERIS ® extended-release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. UCERIS (budesonide) is a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 68012-309
- What is NDC 68012-309?
- 68012-309 is the product NDC for Uceris (budesonide), Budesonide 9 mg/1 tablet, extended release, listed with the FDA by Santarus Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Uceris (Budesonide).
- What is the active ingredient?
- Budesonide.
- Who is the labeler?
- Santarus Inc., NDC labeler code 68012. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Uceris?
- 1 other product NDC are listed under this name. See all Uceris NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Uceris products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ucerisbudesonide | Budesonide 2 mg/1 | Aerosol, FoamRectal | Salix Pharmaceuticals, Inc. | 65649-651 | 65649-0651-03 |
Other NDCs under NDA 203634
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 9 mg/1 | Tablet, Extended releaseOral | Oceanside Pharmaceuticals | 68682-309 |