What is NDC 68083-560?

68083-560 is the product NDC for Octreotide Acetate, Octreotide acetate 500 ug/mL injection, solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Gland Pharma Limited, NDC labeler code 68083. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Octreotide Acetate NDC 68083-560 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-560Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0560Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
68083-560-10	68083056010	10 VIAL in 1 CARTON (68083-560-10) / 1 mL in 1 VIALMarketed from Jun 22, 2023

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 Acetate
Generic name (nonproprietary): octreotide acetate
Active ingredients: Octreotide acetate — 500 ug/mL
Dosage form: Injection, Solution
Route: Intravenous, Subcutaneous
Labeler: Gland Pharma LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216839
Marketing start: Jun 22, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Somatostatin Receptor Agonists (Mechanism)
Identifiers: Product ID 68083-560_723308d0-ea28-4f3f-b993-0bc5cfe33cfeSPL ID 723308d0-ea28-4f3f-b993-0bc5cfe33cfeSPL set ID 884e4287-a4d8-4a6e-8d99-dbe5e88875b9RxCUI 312069, 312070UNII 75R0U2568IUPC 0368083517106, 0368083560102
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.

How CPT relates to drug billing

NDC on a medical claim

N468083056010 followed by a unit qualifier and the quantity

Package 68083-0560-10. 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 Jul 29, 2024.

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.

Full label on DailyMed (opens in a new tab)

About NDC 68083-560

What is NDC 68083-560?: 68083-560 is the product NDC for Octreotide Acetate, Octreotide acetate 500 ug/mL injection, solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Octreotide Acetate.
What is the active ingredient?: Octreotide acetate.
Who is the labeler?: Gland Pharma Limited, NDC labeler code 68083. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Octreotide Acetate NDCs
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	—	KitIntramuscular	Teva Pharmaceuticals, Inc.	0480-9262	00480-9262-08
Octreotide Acetate	Octreotide acetate 100 ug/mL	Injection, SolutionIntravenous, Subcutaneous	Hainan Shuangcheng Pharmaceuticals Co., Ltd.	52958-046	52958-0046-10

All 29 Octreotide Acetate NDCs

Other NDCs under ANDA 216839

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 216839
Product	Strength	Form · route	Labeler	Product NDC
Octreotide Acetate	Octreotide acetate 100 ug/mL	Injection, SolutionIntravenous, Subcutaneous	Gland Pharma Limited	68083-517
Octreotide Acetate	Octreotide acetate 100 ug/mL	Injection, SolutionIntravenous, Subcutaneous	GLENMARK PHARMACEUTICALS INC., USA	68462-896
Octreotide Acetate	Octreotide acetate 500 ug/mL	Injection, SolutionIntravenous, Subcutaneous	GLENMARK PHARMACEUTICALS INC., USA	68462-897