Octreotide Acetate
- Product NDC
- 0641-6177
- 11-digit product format
- 006416177
- Labeler code
- 0641
- Product ID
- 0641-6177_efa5d8e8-57ab-4b56-b8d7-f856ea97404c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Octreotide Acetate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA076330
- Marketing category
- ANDA
- Marketing start
- 2005-04-08
- Substance
- OCTREOTIDE ACETATE
- Active strength
- 200 ug/mL
- Pharmacologic classes
- Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 |
| 8f3fde6c-976e-4e4c-8ed4-542294fcc0ef | Product name | 1 | 20210115 |
| 467fba3a-c020-419e-8102-aeb9c0ea15ec | Product name | 1 | 20200616 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0641-6177-01 | Octreotide Acetate | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 5 | 11 | |
| 0641-6177-01 | Octreotide Acetate | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0641-6177-01 | ML - Milliliter | 0641-6177 | d3f0cf86-5923-45f7-9683-4d8a4de2fee8 | 1 | 2017-11-06 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312069 | octreotide 100 MCG in 1 ML Injection | PSN | 9502860d-0261-4d69-a4be-827a5376d356 | 11 |
| 312071 | octreotide 1000 MCG/ML Injectable Solution | PSN | 9502860d-0261-4d69-a4be-827a5376d356 | 11 |
| 314152 | octreotide 200 MCG/ML Injectable Solution | PSN | 9502860d-0261-4d69-a4be-827a5376d356 | 11 |
| 312068 | octreotide 50 MCG in 1 ML Injection | PSN | 9502860d-0261-4d69-a4be-827a5376d356 | 11 |
| 312070 | octreotide 500 MCG in 1 ML Injection | PSN | 9502860d-0261-4d69-a4be-827a5376d356 | 11 |
| 312068 | 1 ML octreotide 0.05 MG/ML Injection | SCD | 9502860d-0261-4d69-a4be-827a5376d356 | 11 |
| 312069 | 1 ML octreotide 0.1 MG/ML Injection | SCD | 9502860d-0261-4d69-a4be-827a5376d356 | 11 |
| 312070 | 1 ML octreotide 0.5 MG/ML Injection | SCD | 9502860d-0261-4d69-a4be-827a5376d356 | 11 |
| 314152 | octreotide 0.2 MG/ML Injectable Solution | SCD | 9502860d-0261-4d69-a4be-827a5376d356 | 11 |
| 312071 | octreotide 1 MG/ML Injectable Solution | SCD | 9502860d-0261-4d69-a4be-827a5376d356 | 11 |
| 312069 | 1 ML octreotide 100 MCG/ML Injection | SY | 9502860d-0261-4d69-a4be-827a5376d356 | 11 |
| 312070 | 1 ML octreotide 500 MCG/ML Injection | SY | 9502860d-0261-4d69-a4be-827a5376d356 | 11 |
| 312071 | octreotide (as octreotide acetate) 1000 MCG/ML Injectable Solution | SY | 9502860d-0261-4d69-a4be-827a5376d356 | 11 |
| 314152 | octreotide (as octreotide acetate) 200 MCG/ML Injectable Solution | SY | 9502860d-0261-4d69-a4be-827a5376d356 | 11 |
| 312069 | octreotide 100 MCG per 1 ML Injection | SY | 9502860d-0261-4d69-a4be-827a5376d356 | 11 |
| 312068 | octreotide 50 MCG per 1 ML Injection | SY | 9502860d-0261-4d69-a4be-827a5376d356 | 11 |
| 312070 | octreotide 500 MCG per 1 ML Injection | SY | 9502860d-0261-4d69-a4be-827a5376d356 | 11 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0641-6177-01 | 00641617701 | 1 VIAL, MULTI-DOSE in 1 CARTON (0641-6177-01) / 5 mL in 1 VIAL, MULTI-DOSE | 2005-04-08 | 0000-00-00 | No | No | Current |