Prescription drug · ANDA
Octreotide Acetate NDC 0480-9262
Kit · Intramuscular · Teva Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0480-9262-08 | 0048092620800480926208 | 1 KIT in 1 KIT (0480-9262-08) * 8 mL in 1 VIAL, SINGLE-DOSE (0480-9260-01) * 2 mL in 1 SYRINGE (0480-9263-21)Marketed from Oct 1, 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)
- Octreotide Acetate
- Generic name (nonproprietary)
- octreotide acetate
- Dosage form
- Kit
- Route
- Intramuscular
- Labeler
- Teva Pharmaceuticals, Inc.NDC labeler code 0480
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210317
- Marketing start
- Listing expires
- Identifiers
- Product ID 0480-9262_2e77a034-b0ae-4694-8ac0-ae1319754d3aSPL ID 2e77a034-b0ae-4694-8ac0-ae1319754d3aSPL set ID d9739ea6-74de-4a41-a806-6e827a23cedbRxCUI 898589, 898601, 898605
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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400480926208followed by a unit qualifier and the quantityPackage 00480-9262-08. 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)
Octreotide acetate for injectable suspension 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with octreotide acetate injection has been shown to be effective and tolerated. Octreotide acetate for injectable suspension is a somatostatin analogue indicated for: Treatment in patients who have responded to and tolerated octreotide acetate injection subcutaneous injection for: Acromegaly ( 1.1 ) Severe diarrhea/flushing episodes associated with metastatic carcinoid tumors ( 1.2 ) Profuse watery diarrhea associated with Vasoactive Intestinal Peptide (VIP) secreting tumors ( 1.3 ) 1.1 Acromegaly Long-term maintenance therapy in acromegalic patients who have had an inadequ…
Excerpt only. Read the full label for complete information.
About NDC 0480-9262
- What is NDC 0480-9262?
- 0480-9262 is the product NDC for Octreotide Acetate kit, listed with the FDA by Teva Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Octreotide Acetate.
- Who is the labeler?
- Teva Pharmaceuticals, Inc., NDC labeler code 0480. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Octreotide Acetate?
- 28 other product NDCs are listed under this name. See all Octreotide Acetate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Octreotide Acetate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Octreotide Acetate | — | Kit | Mylan Institutional LLC | 67457-756 | 67457-0756-10 |
| Octreotide Acetate | — | Kit | Mylan Institutional LLC | 67457-759 | 67457-0759-20 |
| Octreotide Acetate | — | Kit | Mylan Institutional LLC | 67457-762 | 67457-0762-30 |
| Octreotide Acetate | — | KitIntramuscular | Teva Pharmaceuticals, Inc. | 0480-9257 | 00480-9257-08 |
| Octreotide Acetate | Octreotide acetate 50 ug/mL | Injection, SolutionIntravenous, Subcutaneous | Meitheal Pharmaceuticals, Inc. | 71288-566 | 71288-0566-02 |
| Octreotide Acetate | Octreotide acetate 100 ug/mL | Injection, SolutionIntravenous, Subcutaneous | Meitheal Pharmaceuticals, Inc. | 71288-567 | 71288-0567-02 |
| Octreotide Acetate | Octreotide acetate 500 ug/mL | Injection, SolutionIntravenous, Subcutaneous | Meitheal Pharmaceuticals, Inc. | 71288-568 | 71288-0568-02 |
| Octreotide Acetate | — | KitIntramuscular | Teva Pharmaceuticals, Inc. | 0480-9259 | 00480-9259-08 |
| Octreotide Acetate | Octreotide acetate 100 ug/mL | Injection, SolutionIntravenous, Subcutaneous | Hainan Shuangcheng Pharmaceuticals Co., Ltd. | 52958-046 | 52958-0046-10 |
| Octreotide Acetate | Octreotide acetate 100 ug/mL | Injection, SolutionIntravenous, Subcutaneous | GLENMARK PHARMACEUTICALS INC., USA | 68462-896 | 68462-0896-10 |
Other NDCs under ANDA 210317
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 |
|---|---|---|---|---|
| Octreotide Acetate | — | KitIntramuscular | Teva Pharmaceuticals, Inc. | 0480-9257 |
| Octreotide Acetate | — | KitIntramuscular | Teva Pharmaceuticals, Inc. | 0480-9259 |