Octreotide
- Product NDC
- 63323-378
- 11-digit product format
- 633230378
- Labeler code
- 63323
- Product ID
- 63323-378_02ac0091-573d-41ba-8b4d-5a1d42b89b2e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OCTREOTIDE ACETATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA077450
- Marketing category
- ANDA
- Marketing start
- 2006-03-14
- Substance
- OCTREOTIDE ACETATE
- Active strength
- 200 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OCTREOTIDE ACETATE | 200 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 75R0U2568I |
| Rxcui | 312069, 312070, 312071, 314152 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-378-05 | Octreotide | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 5 | | 9 |
| 63323-378-05 | Octreotide | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OCTREOTIDE ACETATE | ACTIVE INGREDIENT | 75R0U2568I | OCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| OCTREOTIDE | ACTIVE MOIETY | RWM8CCW8GP | OCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | OCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| PHENOL | INACTIVE INGREDIENT | 339NCG44TV | OCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| SODIUM ACETATE | INACTIVE INGREDIENT | 4550K0SC9B | OCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | OCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-378 | OCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240518_f278f0d8-4062-420a-97c3-3a8b88253a08.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 |
|---|
| 63323-378-05 | 63323037805 | 1 VIAL, MULTI-DOSE in 1 CARTON (63323-378-05) / 5 mL in 1 VIAL, MULTI-DOSE | 2006-03-14 | 0000-00-00 | No | No | Current |