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NDC 49502-0378-75 ERMEZA 30 ug/mL Details
ERMEZA 30 ug/mL
ERMEZA is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Specialty L.P.. The primary component is LEVOTHYROXINE SODIUM.
Product Information
| NDC | 49502-0378 |
|---|---|
| Product ID | 49502-378_5bbfafaa-e558-45f5-9ae4-c26aecb5815c |
| Associated GPIs | |
| GCN Sequence Number | 083382 |
| GCN Sequence Number Description | levothyroxine sodium SOLUTION 150MCG/5ML ORAL |
| HIC3 | P3A |
| HIC3 Description | THYROID HORMONES |
| GCN | 52325 |
| HICL Sequence Number | 002849 |
| HICL Sequence Number Description | LEVOTHYROXINE SODIUM |
| Brand/Generic | Brand |
| Proprietary Name | ERMEZA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | levothyroxine sodium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 30 |
| Active Ingredient Units | ug/mL |
| Substance Name | LEVOTHYROXINE SODIUM |
| Labeler Name | Mylan Specialty L.P. |
| Pharmaceutical Class | Thyroxine [CS], l-Thyroxine [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA215809 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 49502-0378-75 (49502037875)
| NDC Package Code | 49502-378-75 |
|---|---|
| Billing NDC | 49502037875 |
| Package | 1 BOTTLE, GLASS in 1 CARTON (49502-378-75) / 75 mL in 1 BOTTLE, GLASS |
| Marketing Start Date | 2022-12-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |