FDA.reportPublic FDA data

RenThyroid

Product NDC
64950-170
11-digit product format
649500170
Labeler code
64950
Product ID
64950-170_dd8b277c-6ec2-4e0b-9aec-c64089e18cfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOTHYROXINE and LIOTHYRONINE
Dosage form
TABLET
Route
ORAL
Labeler
Genus Lifesciences
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-03-01
Substance
LEVOTHYROXINE; LIOTHYRONINE
Active strength
9.5; 2.25 ug/1; ug/1
Pharmacologic classes
Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RenThyroid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE9.5 ug/1
LIOTHYRONINE2.25 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii06LU7C9H1V, Q51BO43MG4
Rxcui198278, 208545, 313387, 313391, 313393, 314267, 2706315, 2706317, 2706319, 2706321, 2706323, 2706325, 2706327, 2706329, 2706331, 2706333

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
97c252d3-9bb8-4530-bb44-9824dc7cf556Product name620250729
b42496cd-a994-8ba1-597f-e507aa62246eProduct name520250116
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
6a33ec05-2ae2-45e5-ab82-2d94b3303923Product name120190709
93355a10-1c44-4c92-a11d-7d995e0200d9Product name120190219
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64950-170-01RenThyroid100 in 1 BOTTLETABLET1001
64950-170-09RenThyroid90 in 1 BOTTLETABLET901
64950-170-14RenThyroid14 in 1 BOTTLETABLET141

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64950-170-01EA - Each64950-17071c74e0e-298f-4c39-ae9c-cd0bdf87e87f12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64950-170RENTHYROID (LEVOTHYROXINE AND LIOTHYRONINE) TABLET [GENUS LIFESCIENCES]1Current NDC, 3 package rows20250302_0f0c1875-7706-43ec-a9ef-ad82a49e46ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2706331RenThyroid 120 MG (2 grain) Oral TabletPSN0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706333RenThyroid 15 MG (1/4 grain) Oral TabletPSN0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706315RenThyroid 180 MG (3 grain) Oral TabletPSN0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706317RenThyroid 30 MG (1/2 grain) Oral TabletPSN0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706321RenThyroid 45 MG (3/4 grain) Oral TabletPSN0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706323RenThyroid 60 MG (1 grain) Oral TabletPSN0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706327RenThyroid 75 MG (1 1/4 grain) Oral TabletPSN0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706329RenThyroid 90 MG (1 1/2 grain) Oral TabletPSN0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706319thyroid (USP) 45 MG (3/4 grain) Oral TabletPSN0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
208545thyroid 120 MG (2 grain) Oral TabletPSN0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
314267thyroid 15 MG (1/4 grain) Oral TabletPSN0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
198278thyroid 180 MG (3 grain) Oral TabletPSN0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
313387thyroid 30 MG (1/2 grain) Oral TabletPSN0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
313391thyroid 60 MG (1 grain) Oral TabletPSN0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706325thyroid 75 MG (1 1/4 grain) Oral TabletPSN0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
313393thyroid 90 MG (1 1/2 grain) Oral TabletPSN0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706331thyroid (USP) 120 MG Oral Tablet [Renthyroid]SBD0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706333thyroid (USP) 15 MG Oral Tablet [Renthyroid]SBD0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706315thyroid (USP) 180 MG Oral Tablet [Renthyroid]SBD0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706317thyroid (USP) 30 MG Oral Tablet [Renthyroid]SBD0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706321thyroid (USP) 45 MG Oral Tablet [Renthyroid]SBD0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706323thyroid (USP) 60 MG Oral Tablet [Renthyroid]SBD0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706327thyroid (USP) 75 MG Oral Tablet [Renthyroid]SBD0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706329thyroid (USP) 90 MG Oral Tablet [Renthyroid]SBD0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
208545thyroid (USP) 120 MG Oral TabletSCD0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
314267thyroid (USP) 15 MG Oral TabletSCD0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
198278thyroid (USP) 180 MG Oral TabletSCD0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
313387thyroid (USP) 30 MG Oral TabletSCD0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706319thyroid (USP) 45 MG Oral TabletSCD0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
313391thyroid (USP) 60 MG Oral TabletSCD0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706325thyroid (USP) 75 MG Oral TabletSCD0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
313393thyroid (USP) 90 MG Oral TabletSCD0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
198278levothyroxine sodium 114 MCG / liothyronine sodium 27 MCG Oral TabletSY0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
313387levothyroxine sodium 19 MCG / liothyronine sodium 4.5 MCG Oral TabletSY0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706319levothyroxine sodium 28.5 MCG / liothyronine sodium 6.75 MCG Oral TabletSY0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
313391levothyroxine sodium 38 MCG / liothyronine sodium 9 MCG Oral TabletSY0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706325levothyroxine sodium 47.5 MCG / liothyronine sodium 11.25 MCG Oral TabletSY0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
313393levothyroxine sodium 57 MCG / liothyronine sodium 13.5 MCG Oral TabletSY0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
208545levothyroxine sodium 76 MCG / liothyronine sodium 18 MCG Oral TabletSY0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
314267levothyroxine sodium 9.5 MCG / liothyronine sodium 2.25 MCG Oral TabletSY0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706315Renthyroid (levothyroxine sodium 114 MCG / liothyronine sodium 27 MCG) Oral TabletSY0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706317Renthyroid (levothyroxine sodium 19 MCG / liothyronine sodium 4.5 MCG) Oral TabletSY0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706321Renthyroid (levothyroxine sodium 28.5 MCG / liothyronine sodium 6.75 MCG) Oral TabletSY0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706323Renthyroid (levothyroxine sodium 38 MCG / liothyronine sodium 9 MCG) Oral TabletSY0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706327Renthyroid (levothyroxine sodium 47.5 MCG / liothyronine sodium 11.25 MCG) Oral TabletSY0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706329Renthyroid (levothyroxine sodium 57 MCG / liothyronine sodium 13.5 MCG) Oral TabletSY0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706331Renthyroid (levothyroxine sodium 76 MCG / liothyronine sodium 18 MCG) Oral TabletSY0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
2706333Renthyroid (levothyroxine sodium 9.5 MCG / liothyronine sodium 2.25 MCG) Oral TabletSY0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
313393thyroid (USP) 1 1/2 grain Oral TabletSY0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
313391thyroid (USP) 1 grain Oral TabletSY0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
313387thyroid (USP) 1/2 grain Oral TabletSY0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
314267thyroid (USP) 1/4 grain Oral TabletSY0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
208545thyroid (USP) 2 grain Oral TabletSY0f0c1875-7706-43ec-a9ef-ad82a49e46ec1
198278thyroid (USP) 3 grain Oral TabletSY0f0c1875-7706-43ec-a9ef-ad82a49e46ec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64950-170-0164950017001100 TABLET in 1 BOTTLE (64950-170-01) 100 tablet2025-03-01NoNoHistorical
64950-170-096495001700990 TABLET in 1 BOTTLE (64950-170-09) 90 tablet2025-03-01NoNoHistorical
64950-170-146495001701414 TABLET in 1 BOTTLE (64950-170-14) 14 tablet2025-03-01NoNoHistorical