Octreotide Acetate
- Product NDC
- 68083-560
- 11-digit product format
- 680830560
- Labeler code
- 68083
- Product ID
- 68083-560_723308d0-ea28-4f3f-b993-0bc5cfe33cfe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Octreotide Acetate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA216839
- Marketing category
- ANDA
- Marketing start
- 2023-06-22
- Substance
- OCTREOTIDE ACETATE
- Active strength
- 500 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 table| Ingredient | Strength |
|---|
| OCTREOTIDE ACETATE | 500 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 75R0U2568I |
| Rxcui | 312069, 312070 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-560-10 | Octreotide Acetate | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 7 |
| 68083-560-10 | Octreotide Acetate | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-560 | OCTREOTIDE ACETATE INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 7 | Current NDC, 2 package rows | 20240805_884e4287-a4d8-4a6e-8d99-dbe5e88875b9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-560-10 | 68083056010 | 10 VIAL in 1 CARTON (68083-560-10) / 1 mL in 1 VIAL | 10 vial | 2023-06-22 | No | No | Historical |