OCTREOTIDE ACETATE
- Product NDC
- 52958-046
- 11-digit product format
- 529580046
- Labeler code
- 52958
- Product ID
- 52958-046_dc2c72fd-ddb4-4933-8ef2-1edfbe7740f2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- octreotide acetate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Hainan Shuangcheng Pharmaceuticals Co., Ltd.
- Application
- ANDA217860
- Marketing category
- ANDA
- Marketing start
- 2024-05-02
- Substance
- OCTREOTIDE ACETATE
- Active strength
- 100 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 | 100 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 75R0U2568I |
| Rxcui | 312069 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52958-046-01 | OCTREOTIDE ACETATE | 1 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 1 | | 3 |
| 52958-046-10 | OCTREOTIDE ACETATE | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52958-046 | OCTREOTIDE ACETATE INJECTION, SOLUTION [HAINAN SHUANGCHENG PHARMACEUTICALS CO., LTD.] | 2 | Current NDC, 2 package rows | 20241222_ab9b0d3d-4dab-4c5b-9c23-3a14f8fcfcde.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 |
|---|
| 52958-046-01 | 52958004601 | 1 mL in 1 VIAL, GLASS | 1 ml | | | | Historical |
| 52958-046-10 | 52958004610 | 10 VIAL, GLASS in 1 CARTON (52958-046-10) / 1 mL in 1 VIAL, GLASS (52958-046-01) | | 2024-05-02 | No | No | Current |