Prescription drug · ANDA
Octreotide (Octreotide acetate) NDC 63323-378
Octreotide acetate 200 ug/mL · Injection, Solution · Intravenous, Subcutaneous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-378-05 | 63323037805 | 1 VIAL, MULTI-DOSE in 1 CARTON (63323-378-05) / 5 mL in 1 VIAL, MULTI-DOSEMarketed from Mar 14, 2006 |
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)
- Octreotide
- Generic name (nonproprietary)
- octreotide acetate
- Active ingredients
- Octreotide acetate — 200 ug/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous, Subcutaneous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077450
- Marketing start
- Listing expires
- Other FDA classes
- Somatostatin Receptor Agonists (Mechanism)
- Identifiers
- Product ID 63323-378_02ac0091-573d-41ba-8b4d-5a1d42b89b2eSPL ID 02ac0091-573d-41ba-8b4d-5a1d42b89b2eSPL set ID f278f0d8-4062-420a-97c3-3a8b88253a08RxCUI 312069, 312070, 312071, 314152UNII 75R0U2568IUPC 0363323378059, 0363323376000, 0363323379056, 0363323377007
- Pharmacologic class
- Somatostatin Analog
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
N463323037805followed by a unit qualifier and the quantityPackage 63323-0378-05. 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 Injection is a somatostatin analogue indicated: Acromegaly : To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. ( 1.1 ) Carcinoid Tumors : For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. ( 1.2 ) Vasoactive Intestinal Peptide Tumors (VIPomas) : For the treatment of profuse watery diarrhea associated with VIP-secreting t…
Excerpt only. Read the full label for complete information.
About NDC 63323-378
- What is NDC 63323-378?
- 63323-378 is the product NDC for Octreotide (octreotide acetate), Octreotide acetate 200 ug/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Octreotide (Octreotide acetate).
- What is the active ingredient?
- Octreotide acetate.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. 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?
- 5 other product NDCs are listed under this name. See all Octreotide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Octreotide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Octreotideoctreotide acetate | Octreotide acetate 100 ug/mL | Injection, SolutionIntravenous, Subcutaneous | Fresenius Kabi USA, LLC | 63323-376 | 63323-0376-01 |
| Octreotideoctreotide acetate | Octreotide acetate 100 ug/mL | Injection, SolutionIntravenous, Subcutaneous | Fresenius Kabi USA, LLC | 63323-376 | 63323-0376-04 |
| Octreotideoctreotide acetate | Octreotide acetate 500 ug/mL | Injection, SolutionIntravenous, Subcutaneous | Fresenius Kabi USA, LLC | 63323-377 | 63323-0377-01 |
| Octreotideoctreotide acetate | Octreotide acetate 500 ug/mL | Injection, SolutionIntravenous, Subcutaneous | Fresenius Kabi USA, LLC | 63323-377 | 63323-0377-04 |
| Octreotideoctreotide acetate | Octreotide acetate 1000 ug/mL | Injection, SolutionIntravenous, Subcutaneous | Fresenius Kabi USA, LLC | 63323-379 | 63323-0379-05 |
Other NDCs under ANDA 077450
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 |
|---|---|---|---|---|
| Octreotideoctreotide acetate | Octreotide acetate 1000 ug/mL | Injection, SolutionIntravenous, Subcutaneous | Fresenius Kabi USA, LLC | 63323-379 |