FDA.reportPublic FDA data

RenThyroid

Product NDC
64950-174
Requested package NDC
64950-174-14
11-digit product format
649500174
Labeler code
64950
Product ID
64950-174_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
76; 18 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
LEVOTHYROXINE76 ug/1
LIOTHYRONINE18 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Q51BO43MG4Internal UNII lookup
06LU7C9H1VInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 16 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198278Internal RxNorm lookup
208545Internal RxNorm lookup
313387Internal RxNorm lookup
313391Internal RxNorm lookup
313393Internal RxNorm lookup
314267Internal RxNorm lookup
2706315Internal RxNorm lookup
2706317Internal RxNorm lookup
2706319Internal RxNorm lookup
2706321Internal RxNorm lookup
2706323Internal RxNorm lookup
2706325Internal RxNorm lookup
2706327Internal RxNorm lookup
2706329Internal RxNorm lookup
2706331Internal RxNorm lookup
2706333Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0f0c1875-7706-43ec-a9ef-ad82a49e46ecAvailable on FDA.report

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
64950-174-01RenThyroid100 in 1 BOTTLETABLET1001
64950-174-09RenThyroid90 in 1 BOTTLETABLET901
64950-174-14RenThyroid14 in 1 BOTTLETABLET141

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64950-174-01EA - Each64950-17407dabd29-c2df-4b98-aad5-6c42a6d3eed812025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64950-174RENTHYROID (LEVOTHYROXINE AND LIOTHYRONINE) TABLET [GENUS LIFESCIENCES]1Current NDC, 3 package rows20250302_0f0c1875-7706-43ec-a9ef-ad82a49e46ec.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RenThyroidLEVOTHYROXINE AND LIOTHYRONINEGenus Lifesciences0f0c1875-7706-43ec-a9ef-ad82a49e46ec2025-02-27Warnings, Adverse reactionsExact identifier
ndc (package): 64950-174-14
ndc (product): 64950-174
ndc11 (package): 64950017414

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
64950-174-146495001741414 TABLET in 1 BOTTLE (64950-174-14) 14 tablet2025-03-01NoNoCurrent