Octreotide Acetate
- Product NDC
- 25021-467
- 11-digit product format
- 250210467
- Labeler code
- 25021
- Product ID
- 25021-467_5e508c59-4170-441a-a94a-70b0bf28b8e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- octreotide acetate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA091041
- Marketing category
- ANDA
- Marketing start
- 2023-06-15
- Substance
- OCTREOTIDE ACETATE
- Active strength
- 1000 ug/mL
- Pharmacologic classes
- Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Octreotide Acetate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OCTREOTIDE ACETATE | 1000 ug/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 75R0U2568I |
| Rxcui | 312068, 312069, 312070, 312071, 314152 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 813db1d8-6534-4d2d-be9e-8d2c20a55eda | Product name | 1 | 20241217 |
| a6ddfef5-d553-2919-73fa-8aede2a8ab27 | Product name | 5 | 20240823 |
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 8f3fde6c-976e-4e4c-8ed4-542294fcc0ef | Product name | 1 | 20210115 |
| 467fba3a-c020-419e-8102-aeb9c0ea15ec | Product name | 1 | 20200616 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 25021-467-05 | Octreotide Acetate | 5 mL in 1 VIAL | INJECTION, SOLUTION | 5 | 10 | |
| 25021-467-05 | Octreotide Acetate | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 25021-467-05 | ML - Milliliter | 25021-467 | 8a2997dd-9fbc-43f4-8331-e1ee9b3450c6 | 1 | 2024-05-16 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312069 | octreotide 100 MCG in 1 ML Injection | PSN | 7ce2fc1e-7520-4d04-be45-2baba32ca24a | 10 |
| 312071 | octreotide 1000 MCG/ML Injectable Solution | PSN | 7ce2fc1e-7520-4d04-be45-2baba32ca24a | 10 |
| 314152 | octreotide 200 MCG/ML Injectable Solution | PSN | 7ce2fc1e-7520-4d04-be45-2baba32ca24a | 10 |
| 312068 | octreotide 50 MCG in 1 ML Injection | PSN | 7ce2fc1e-7520-4d04-be45-2baba32ca24a | 10 |
| 312070 | octreotide 500 MCG in 1 ML Injection | PSN | 7ce2fc1e-7520-4d04-be45-2baba32ca24a | 10 |
| 312068 | 1 ML octreotide 0.05 MG/ML Injection | SCD | 7ce2fc1e-7520-4d04-be45-2baba32ca24a | 10 |
| 312069 | 1 ML octreotide 0.1 MG/ML Injection | SCD | 7ce2fc1e-7520-4d04-be45-2baba32ca24a | 10 |
| 312070 | 1 ML octreotide 0.5 MG/ML Injection | SCD | 7ce2fc1e-7520-4d04-be45-2baba32ca24a | 10 |
| 314152 | octreotide 0.2 MG/ML Injectable Solution | SCD | 7ce2fc1e-7520-4d04-be45-2baba32ca24a | 10 |
| 312071 | octreotide 1 MG/ML Injectable Solution | SCD | 7ce2fc1e-7520-4d04-be45-2baba32ca24a | 10 |
| 312069 | 1 ML octreotide 100 MCG/ML Injection | SY | 7ce2fc1e-7520-4d04-be45-2baba32ca24a | 10 |
| 312070 | 1 ML octreotide 500 MCG/ML Injection | SY | 7ce2fc1e-7520-4d04-be45-2baba32ca24a | 10 |
| 312071 | octreotide (as octreotide acetate) 1000 MCG/ML Injectable Solution | SY | 7ce2fc1e-7520-4d04-be45-2baba32ca24a | 10 |
| 314152 | octreotide (as octreotide acetate) 200 MCG/ML Injectable Solution | SY | 7ce2fc1e-7520-4d04-be45-2baba32ca24a | 10 |
| 312069 | octreotide 100 MCG per 1 ML Injection | SY | 7ce2fc1e-7520-4d04-be45-2baba32ca24a | 10 |
| 312068 | octreotide 50 MCG per 1 ML Injection | SY | 7ce2fc1e-7520-4d04-be45-2baba32ca24a | 10 |
| 312070 | octreotide 500 MCG per 1 ML Injection | SY | 7ce2fc1e-7520-4d04-be45-2baba32ca24a | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 25021-467-05 | 25021046705 | 1 VIAL in 1 CARTON (25021-467-05) / 5 mL in 1 VIAL | 1 vial | 2023-06-15 | 0000-00-00 | No | No | Current |