Omnitrope
- Product NDC
- 0781-3001
- 11-digit product format
- 007813001
- Labeler code
- 0781
- Product ID
- 0781-3001_22eba20c-aa55-440d-846e-a1235440fecb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Somatropin
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Sandoz Inc
- Application
- BLA021426
- Marketing category
- BLA
- Marketing start
- 2006-05-30
- Substance
- SOMATROPIN
- Active strength
- 5 mg/1.5mL
- Pharmacologic classes
- Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Omnitrope
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SOMATROPIN | 5 mg/1.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NQX9KB6PCL |
| Rxcui | 241975, 645884, 854302, 864110, 1736267, 1736337 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0781-3001-07 | Omnitrope | 1.5 mL in 1 CARTRIDGE | INJECTION, SOLUTION | 1.5 | | 36 |
| 0781-3001-07 | Omnitrope | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 36 |
| 0781-3001-26 | Omnitrope | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | | 36 |
| 0781-3001-26 | Omnitrope | 1.5 mL in 1 CARTRIDGE | INJECTION, SOLUTION | 1.5 | | 36 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SOMATROPIN | ACTIVE INGREDIENT | NQX9KB6PCL | OMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC] | 24 | |
| SOMATROPIN | ACTIVE MOIETY | NQX9KB6PCL | OMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC] | 24 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | OMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC] | 24 | |
| GLYCINE | INACTIVE INGREDIENT | TE7660XO1C | OMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC] | 24 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | OMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC] | 24 | |
| PHENOL | INACTIVE INGREDIENT | 339NCG44TV | OMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC] | 24 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | OMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC] | 24 | |
| SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE | INACTIVE INGREDIENT | 70WT22SF4B | OMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC] | 24 | |
| SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | INACTIVE INGREDIENT | 5QWK665956 | OMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC] | 24 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | OMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC] | 24 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0781-3001 | OMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC] | 34 | Current NDC, Legacy NDC, 4 package rows | 20241215_58d84ffa-4056-4e36-ad67-7bd4aef444a5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0781-3001-07 | 00781300107 | 1 CARTRIDGE in 1 CARTON (0781-3001-07) / 1.5 mL in 1 CARTRIDGE | 1 cartridge | 2006-05-30 | 0000-00-00 | No | No | Current |
| 0781-3001-26 | 00781300126 | 5 CARTRIDGE in 1 CARTON (0781-3001-26) / 1.5 mL in 1 CARTRIDGE | 5 cartridge | 2006-05-30 | 0000-00-00 | No | No | Current |