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NDC 25021-0452-01 Octreotide Acetate 100 ug/mL Details
Octreotide Acetate 100 ug/mL
Octreotide Acetate is a INTRAVENOUS; SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sagent Pharmaceuticals. The primary component is OCTREOTIDE ACETATE.
MedlinePlus Drug Summary
Octreotide immediate-release injection is used to decrease the amount of growth hormone (a natural substance) produced by people with acromegaly (condition in which the body produces too much growth hormone, causing enlargement of the hands, feet, and facial features; joint pain; and other symptoms) who cannot be treated with surgery, radiation, or another medication. Octreotide immediate-release injection is also used to control diarrhea and flushing caused by carcinoid tumors (slow-growing tumors that release natural substances that can cause symptoms) and vasoactive intestinal peptide secreting adenomas (VIP-omas; tumors that form in the pancreas and release natural substances that can cause symptoms). Octreotide long-acting injection is used to control acromegaly, carcinoid tumors, and VIP-omas in people who have been successfully treated with octreotide injection but prefer to receive injections less often. Octreotide injection is in a class of medications called octapeptides. It works by decreasing the amounts of certain natural substances produced by the body.
Related Packages: 25021-0452-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Octreotide Injection
Product Information
| NDC | 25021-0452 |
|---|---|
| Product ID | 25021-452_8fc24dd7-c1e2-45dd-9de2-3428843da4df |
| Associated GPIs | 30170070102010 |
| GCN Sequence Number | 053978 |
| GCN Sequence Number Description | octreotide acetate VIAL 100 MCG/ML INJECTION |
| HIC3 | P1B |
| HIC3 Description | SOMATOSTATIC AGENTS |
| GCN | 21767 |
| HICL Sequence Number | 002826 |
| HICL Sequence Number Description | OCTREOTIDE ACETATE |
| Brand/Generic | Generic |
| Proprietary Name | Octreotide Acetate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | octreotide acetate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS; SUBCUTANEOUS |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | ug/mL |
| Substance Name | OCTREOTIDE ACETATE |
| Labeler Name | Sagent Pharmaceuticals |
| Pharmaceutical Class | Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090834 |
| Listing Certified Through | 2022-12-31 |
Package
NDC 25021-0452-01 (25021045201)
| NDC Package Code | 25021-452-01 |
|---|---|
| Billing NDC | 25021045201 |
| Package | 10 VIAL in 1 CARTON (25021-452-01) / 1 mL in 1 VIAL |
| Marketing Start Date | 2013-12-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |