Thyrogen
- Product NDC
- 58468-0030
- 11-digit product format
- 584680030
- Labeler code
- 58468
- Product ID
- 58468-0030_a62de867-ea60-47eb-873a-788223a1181f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- THYROTROPIN ALFA
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Genzyme Corporation
- Application
- BLA020898
- Marketing category
- BLA
- Marketing start
- 1998-11-30
- Substance
- THYROTROPIN ALFA
- Active strength
- .9 mg/mL
- Pharmacologic classes
- Thyroid Stimulating Hormone [EPC], Thyrotropin [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Thyrogen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| THYROTROPIN ALFA | .9 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AVX3D5A4LM |
| Rxcui | 2166572, 2166573, 2166578, 2166579, 2554801, 2554802, 2554804, 2554805 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58468-0030-1 | Thyrogen | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 20 |
| 58468-0030-2 | Thyrogen | 2 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 2 | | 20 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| THYROTROPIN ALFA | ACTIVE INGREDIENT | AVX3D5A4LM | THYROGEN (THYROTROPIN ALFA) INJECTION, POWDER, FOR SOLUTION THYROGEN (THYROTROPIN ALFA) KIT [GENZYME CORPORATION] | 12 | |
| THYROTROPIN ALFA | ACTIVE MOIETY | AVX3D5A4LM | THYROGEN (THYROTROPIN ALFA) INJECTION, POWDER, FOR SOLUTION THYROGEN (THYROTROPIN ALFA) KIT [GENZYME CORPORATION] | 12 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | THYROGEN (THYROTROPIN ALFA) INJECTION, POWDER, FOR SOLUTION THYROGEN (THYROTROPIN ALFA) KIT [GENZYME CORPORATION] | 12 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | THYROGEN (THYROTROPIN ALFA) INJECTION, POWDER, FOR SOLUTION THYROGEN (THYROTROPIN ALFA) KIT [GENZYME CORPORATION] | 12 | |
| SODIUM PHOSPHATE | INACTIVE INGREDIENT | SE337SVY37 | THYROGEN (THYROTROPIN ALFA) INJECTION, POWDER, FOR SOLUTION THYROGEN (THYROTROPIN ALFA) KIT [GENZYME CORPORATION] | 12 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | THYROGEN (THYROTROPIN ALFA) INJECTION, POWDER, FOR SOLUTION THYROGEN (THYROTROPIN ALFA) KIT [GENZYME CORPORATION] | 12 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58468-0030 | THYROGEN (THYROTROPIN ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION THYROGEN (THYROTROPIN ALFA) KIT [GENZYME CORPORATION] | 20 | Current NDC, Legacy NDC, 2 package rows | 20230306_b52dfa36-f90b-4e19-9b5e-26db9d04df2b.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 |
|---|
| 58468-0030-1 | 58468003001 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | | Historical |
| 58468-0030-2 | 58468003002 | 2 VIAL, SINGLE-DOSE in 1 CARTON (58468-0030-2) / 1 mL in 1 VIAL, SINGLE-DOSE (58468-0030-1) | | 1998-11-30 | 0000-00-00 | No | No | Current |