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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Octreotide Acetate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OCTREOTIDE ACETATE | 200 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 75R0U2568I |
| Rxcui | 312068, 312069, 312070, 312071, 314152 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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 Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0641-6177 | OCTREOTIDE ACETATE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20250515_9502860d-0261-4d69-a4be-827a5376d356.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 |