FDA.reportPublic FDA data

ERMEZA

Product NDC
49502-378
11-digit product format
495020378
Labeler code
49502
Product ID
49502-378_97c0bb6f-0f8d-414d-88eb-a1590aeaeb9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
SOLUTION
Route
ORAL
Labeler
Viatris Specialty LLC
Application
NDA215809
Marketing category
NDA
Marketing start
2022-12-14
Marketing end
2026-07-31
Substance
LEVOTHYROXINE SODIUM
Active strength
30 ug/mL
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ERMEZA

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM30 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui2626050, 2626056

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
97c252d3-9bb8-4530-bb44-9824dc7cf556Product name620250729
6c43b71c-35e6-4db3-ba24-c6ef42ff7003Product name320240207
890fd4bf-1a80-42b7-be1b-2d0259d5f0c8Product name520240207
c8ad26bf-af73-460b-b74e-1eff16cc4f9fProduct name520240207
01383843-4069-43cf-aa76-dc17a6f9f8c4Product name220230123
978cca7d-a938-4791-8322-da48d90a63efProduct name120230113
65f86ba3-8816-4e12-899b-18290c8de551Product name220210614
f16ab90f-08c2-40be-a543-66d9827cd1f3Product name120210601
6a33ec05-2ae2-45e5-ab82-2d94b3303923Product name120190709
93355a10-1c44-4c92-a11d-7d995e0200d9Product name120190219

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49502-378-15ERMEZA150 mL in 1 BOTTLE, GLASSSOLUTION1506
49502-378-15ERMEZA1 in 1 CARTONSOLUTION16
49502-378-75ERMEZA1 in 1 CARTONSOLUTION16
49502-378-75ERMEZA75 mL in 1 BOTTLE, GLASSSOLUTION756

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49502-378-15ML - Milliliter49502-37811d7c7b1-d981-4fcb-8623-b8c31770775412022-12-07
49502-378-75ML - Milliliter49502-3787693b643-67bc-4b55-9e7c-e33e54c50e0112022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49502-378ERMEZA (LEVOTHYROXINE SODIUM) SOLUTION [VIATRIS SPECIALTY LLC]5Current NDC, Legacy NDC, 4 package rows20250216_8ceeadb4-18be-46c7-9204-68b4edfbb96b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2626056Ermeza 150 MCG in 5 mL Oral SolutionPSN8ceeadb4-18be-46c7-9204-68b4edfbb96b6
2626050levothyroxine sodium 150 MCG in 5 mL Oral SolutionPSN8ceeadb4-18be-46c7-9204-68b4edfbb96b6
2626056levothyroxine sodium 0.03 MG/ML Oral Solution [Ermeza]SBD8ceeadb4-18be-46c7-9204-68b4edfbb96b6
2626050levothyroxine sodium 0.03 MG/ML Oral SolutionSCD8ceeadb4-18be-46c7-9204-68b4edfbb96b6
2626056Ermeza 0.03 MG/ML Oral SolutionSY8ceeadb4-18be-46c7-9204-68b4edfbb96b6
2626056Ermeza 150 MCG per 5 ML Oral SolutionSY8ceeadb4-18be-46c7-9204-68b4edfbb96b6
2626056Ermeza 30 MCG per ML Oral SolutionSY8ceeadb4-18be-46c7-9204-68b4edfbb96b6
2626050levothyroxine sodium 150 MCG per 5 ML Oral SolutionSY8ceeadb4-18be-46c7-9204-68b4edfbb96b6
2626050levothyroxine sodium 30 MCG per ML Oral SolutionSY8ceeadb4-18be-46c7-9204-68b4edfbb96b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49502-378-15495020378151 BOTTLE, GLASS in 1 CARTON (49502-378-15) / 150 mL in 1 BOTTLE, GLASS2022-12-142026-07-31NoNoCurrent
49502-378-75495020378751 BOTTLE, GLASS in 1 CARTON (49502-378-75) / 75 mL in 1 BOTTLE, GLASS2022-12-142026-07-31NoNoCurrent