Prescription drug · NDA
Uceris (Budesonide) NDC 65649-651
Budesonide 2 mg/1 · Aerosol, Foam · Rectal · Salix Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65649-651-03 | 6564906510365649065103 | 2 CANISTER in 1 CARTON (65649-651-03) / 1 AEROSOL, FOAM in 1 CANISTER (65649-651-02)Marketed from Dec 1, 2014 |
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 — 2 mg/1
- Dosage form
- Aerosol, Foam
- Route
- Rectal
- Labeler
- Salix Pharmaceuticals, Inc.NDC labeler code 65649
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205613
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 65649-651_205783ee-5004-4fcb-a9d6-ce1ac824357cSPL ID 205783ee-5004-4fcb-a9d6-ce1ac824357cSPL set ID 230e4596-2a9b-4d55-b0a0-0cabbcff5289RxCUI 1596778, 1596779UNII 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
N465649065103followed by a unit qualifier and the quantityPackage 65649-0651-03. 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 rectal foam is indicated for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge. UCERIS rectal foam is a glucocorticosteroid indicated for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 65649-651
- What is NDC 65649-651?
- 65649-651 is the product NDC for Uceris (budesonide), Budesonide 2 mg/1 aerosol, foam, listed with the FDA by Salix Pharmaceuticals, Inc.. It has 1 package NDC, 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?
- Salix Pharmaceuticals, Inc., NDC labeler code 65649. 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 9 mg/1 | Tablet, Extended releaseOral | Santarus Inc. | 68012-309 | 68012-0309-0168012-0309-0268012-0309-30 |
Other NDCs under NDA 205613
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 2 mg/1 | Aerosol, FoamRectal | Oceanside Pharmaceuticals | 68682-658 |