FDA.reportPublic FDA data

NP Thyroid 90

Product NDC
42192-331
11-digit product format
421920331
Labeler code
42192
Product ID
42192-331_49655b7a-d522-d5e1-e063-6394a90a3727
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOTHYROXINE, LIOTHYRONINE
Dosage form
TABLET
Route
ORAL
Labeler
Acella Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-02-03
Substance
LEVOTHYROXINE; LIOTHYRONINE
Active strength
57; 13.5 ug/1; ug/1
Pharmacologic classes
Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NP Thyroid 90
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE57 ug/1
LIOTHYRONINE13.5 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii06LU7C9H1V, Q51BO43MG4
Rxcui208545, 313387, 313391, 313393, 314267, 1724437, 1724439, 1724481, 1855086, 1923809

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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
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
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42192-331-01NP Thyroid 90100 in 1 BOTTLETABLET10018
42192-331-10NP Thyroid 901000 in 1 BOTTLETABLET100018
42192-331-30NP Thyroid 9030 in 1 BOTTLETABLET3018
42192-331-90NP Thyroid 9090 in 1 BOTTLETABLET9018
42192-331-01NP Thyroid 90100 in 1 BOTTLETABLET10015
42192-331-10NP Thyroid 901000 in 1 BOTTLETABLET100015
42192-331-30NP Thyroid 9030 in 1 BOTTLETABLET3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-331-01EA - Each42192-331e66c8ed9-3953-40d7-8e45-029e844286c612012-07-24
42192-331-10EA - Each42192-331e28f9215-ce62-4b89-9620-3d6330bb856c12025-05-14
42192-331-30EA - Each42192-331f7af6235-54a1-4a63-b3e8-65018bae37d212025-05-14
42192-331-90EA - Each42192-33182d55bb1-4af3-4e66-80d5-47195ac1f5a212026-03-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOTHYROXINEACTIVE INGREDIENTQ51BO43MG4NP THYROID 90 (LEVOTHYROXINE, LIOTHYRONINE) TABLET [ACELLA PHARMACEUTICALS, LLC]1
LIOTHYRONINEACTIVE INGREDIENT06LU7C9H1VNP THYROID 90 (LEVOTHYROXINE, LIOTHYRONINE) TABLET [ACELLA PHARMACEUTICALS, LLC]1
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4NP THYROID 90 (LEVOTHYROXINE, LIOTHYRONINE) TABLET [ACELLA PHARMACEUTICALS, LLC]1
LIOTHYRONINEACTIVE MOIETY06LU7C9H1VNP THYROID 90 (LEVOTHYROXINE, LIOTHYRONINE) TABLET [ACELLA PHARMACEUTICALS, LLC]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LNP THYROID 90 (LEVOTHYROXINE, LIOTHYRONINE) TABLET [ACELLA PHARMACEUTICALS, LLC]1
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GNP THYROID 90 (LEVOTHYROXINE, LIOTHYRONINE) TABLET [ACELLA PHARMACEUTICALS, LLC]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DNP THYROID 90 (LEVOTHYROXINE, LIOTHYRONINE) TABLET [ACELLA PHARMACEUTICALS, LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPNP THYROID 90 (LEVOTHYROXINE, LIOTHYRONINE) TABLET [ACELLA PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-331NP THYROID 90 (LEVOTHYROXINE, LIOTHYRONINE) TABLET [ACELLA PHARMACEUTICALS, LLC]14Current NDC, Legacy NDC, 3 package rows20250309_dac99035-9098-4710-bf55-c46889ffc282.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923809NP Thyroid 120 MG Oral TabletPSNa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
1855086NP Thyroid 15 MG Oral TabletPSNa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
1724439NP Thyroid 30 MG Oral TabletPSNa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
1724481NP Thyroid 60 MG Oral TabletPSNa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
1724437NP Thyroid 90 MG Oral TabletPSNa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
208545thyroid 120 MG (2 grain) Oral TabletPSNa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
314267thyroid 15 MG (1/4 grain) Oral TabletPSNa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
313387thyroid 30 MG (1/2 grain) Oral TabletPSNa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
313391thyroid 60 MG (1 grain) Oral TabletPSNa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
313393thyroid 90 MG (1 1/2 grain) Oral TabletPSNa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
1923809thyroid (USP) 120 MG Oral Tablet [NP Thyroid]SBDa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
1855086thyroid (USP) 15 MG Oral Tablet [NP Thyroid]SBDa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
1724439thyroid (USP) 30 MG Oral Tablet [NP Thyroid]SBDa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
1724481thyroid (USP) 60 MG Oral Tablet [NP Thyroid]SBDa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
1724437thyroid (USP) 90 MG Oral Tablet [NP Thyroid]SBDa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
208545thyroid (USP) 120 MG Oral TabletSCDa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
314267thyroid (USP) 15 MG Oral TabletSCDa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
313387thyroid (USP) 30 MG Oral TabletSCDa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
313391thyroid (USP) 60 MG Oral TabletSCDa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
313393thyroid (USP) 90 MG Oral TabletSCDa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
313387levothyroxine sodium 19 MCG / liothyronine sodium 4.5 MCG Oral TabletSYa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
313391levothyroxine sodium 38 MCG / liothyronine sodium 9 MCG Oral TabletSYa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
313393levothyroxine sodium 57 MCG / liothyronine sodium 13.5 MCG Oral TabletSYa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
208545levothyroxine sodium 76 MCG / liothyronine sodium 18 MCG Oral TabletSYa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
314267levothyroxine sodium 9.5 MCG / liothyronine sodium 2.25 MCG Oral TabletSYa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
1724439NP Thyroid (levothyroxine sodium 19 MCG / liothyronine sodium 4.5 MCG) Oral TabletSYa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
1724481NP Thyroid (levothyroxine sodium 38 MCG / liothyronine sodium 9 MCG) Oral TabletSYa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
1724437NP Thyroid (levothyroxine sodium 57 MCG / liothyronine sodium 13.5 MCG) Oral TabletSYa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
1923809NP Thyroid (levothyroxine sodium 76 MCG / liothyronine sodium 18 MCG) Oral TabletSYa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
1855086NP Thyroid (levothyroxine sodium 9.5 MCG / liothyronine sodium 2.25 MCG) Oral TabletSYa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
1724437NP Thyroid 1 1/2 grain Oral TabletSYa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
1724481NP Thyroid 1 grain Oral TabletSYa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
1724439NP Thyroid 1/2 grain Oral TabletSYa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
1923809NP Thyroid 120 MG Oral TabletSYa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
1855086NP Thyroid 15 MG Oral TabletSYa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
1923809NP Thyroid 2 grains Oral TabletSYa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
1724439NP Thyroid 30 MG Oral TabletSYa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
1724481NP Thyroid 60 MG Oral TabletSYa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
1724437NP Thyroid 90 MG Oral TabletSYa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
313393thyroid (USP) 1 1/2 grain Oral TabletSYa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
313391thyroid (USP) 1 grain Oral TabletSYa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
313387thyroid (USP) 1/2 grain Oral TabletSYa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
314267thyroid (USP) 1/4 grain Oral TabletSYa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
208545thyroid (USP) 2 grain Oral TabletSYa3ff93ad-86ed-4324-ae86-7e7ed3a49db818
1724437NP Thyroid 90 MG Oral TabletPSNdac99035-9098-4710-bf55-c46889ffc28215
313393thyroid 90 MG (1 1/2 grain) Oral TabletPSNdac99035-9098-4710-bf55-c46889ffc28215
1724437thyroid (USP) 90 MG Oral Tablet [NP Thyroid]SBDdac99035-9098-4710-bf55-c46889ffc28215
313393thyroid (USP) 90 MG Oral TabletSCDdac99035-9098-4710-bf55-c46889ffc28215
313393levothyroxine sodium 57 MCG / liothyronine sodium 13.5 MCG Oral TabletSYdac99035-9098-4710-bf55-c46889ffc28215
1724437NP Thyroid (levothyroxine sodium 57 MCG / liothyronine sodium 13.5 MCG) Oral TabletSYdac99035-9098-4710-bf55-c46889ffc28215
1724437NP Thyroid 1 1/2 grain Oral TabletSYdac99035-9098-4710-bf55-c46889ffc28215
1724437NP Thyroid 90 MG Oral TabletSYdac99035-9098-4710-bf55-c46889ffc28215
313393thyroid (USP) 1 1/2 grain Oral TabletSYdac99035-9098-4710-bf55-c46889ffc28215
1724437NP Thyroid 90 MG Oral TabletPSNbc6c190c-e813-4fff-b8aa-4848d45a81435
1724437NP Thyroid 90 MG Oral TabletPSN8edf644d-87f4-4141-85de-5f0c6f963ea35
313393thyroid 90 MG (1 1/2 grain) Oral TabletPSN8edf644d-87f4-4141-85de-5f0c6f963ea35
313393thyroid 90 MG (1 1/2 grain) Oral TabletPSNbc6c190c-e813-4fff-b8aa-4848d45a81435
1724437thyroid (USP) 90 MG Oral Tablet [NP Thyroid]SBDbc6c190c-e813-4fff-b8aa-4848d45a81435
1724437thyroid (USP) 90 MG Oral Tablet [NP Thyroid]SBD8edf644d-87f4-4141-85de-5f0c6f963ea35
313393thyroid (USP) 90 MG Oral TabletSCDbc6c190c-e813-4fff-b8aa-4848d45a81435
313393thyroid (USP) 90 MG Oral TabletSCD8edf644d-87f4-4141-85de-5f0c6f963ea35
313393levothyroxine sodium 57 MCG / liothyronine sodium 13.5 MCG Oral TabletSYbc6c190c-e813-4fff-b8aa-4848d45a81435
313393levothyroxine sodium 57 MCG / liothyronine sodium 13.5 MCG Oral TabletSY8edf644d-87f4-4141-85de-5f0c6f963ea35
1724437NP Thyroid (levothyroxine sodium 57 MCG / liothyronine sodium 13.5 MCG) Oral TabletSYbc6c190c-e813-4fff-b8aa-4848d45a81435
1724437NP Thyroid (levothyroxine sodium 57 MCG / liothyronine sodium 13.5 MCG) Oral TabletSY8edf644d-87f4-4141-85de-5f0c6f963ea35
1724437NP Thyroid 1 1/2 grain Oral TabletSYbc6c190c-e813-4fff-b8aa-4848d45a81435
1724437NP Thyroid 1 1/2 grain Oral TabletSY8edf644d-87f4-4141-85de-5f0c6f963ea35
1724437NP Thyroid 90 MG Oral TabletSY8edf644d-87f4-4141-85de-5f0c6f963ea35
1724437NP Thyroid 90 MG Oral TabletSYbc6c190c-e813-4fff-b8aa-4848d45a81435
313393thyroid (USP) 1 1/2 grain Oral TabletSYbc6c190c-e813-4fff-b8aa-4848d45a81435
313393thyroid (USP) 1 1/2 grain Oral TabletSY8edf644d-87f4-4141-85de-5f0c6f963ea35
1724437NP Thyroid 90 MG Oral TabletPSN3beb6087-3bc0-2d65-e063-6294a90a61a41
1724437NP Thyroid 90 MG Oral TabletPSN3bf259f5-59b4-de7e-e063-6294a90a43761
1724437NP Thyroid 90 MG Oral TabletPSN3bdbada4-9dc8-3fbc-e063-6394a90a4e501
1724437NP Thyroid 90 MG Oral TabletPSNf338ce4a-f180-4cb9-bf9a-5f641e1fa97c1
313393thyroid 90 MG (1 1/2 grain) Oral TabletPSNf338ce4a-f180-4cb9-bf9a-5f641e1fa97c1
313393thyroid 90 MG (1 1/2 grain) Oral TabletPSN3bdbada4-9dc8-3fbc-e063-6394a90a4e501
313393thyroid 90 MG (1 1/2 grain) Oral TabletPSN3bf259f5-59b4-de7e-e063-6294a90a43761
313393thyroid 90 MG (1 1/2 grain) Oral TabletPSN3beb6087-3bc0-2d65-e063-6294a90a61a41
1724437thyroid (USP) 90 MG Oral Tablet [NP Thyroid]SBD3bdbada4-9dc8-3fbc-e063-6394a90a4e501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42192-331-0142192033101100 TABLET in 1 BOTTLE (42192-331-01) 100 tablet2011-02-030000-00-00NoNoCurrent
42192-331-10421920331101000 TABLET in 1 BOTTLE (42192-331-10) 1000 tablet2025-03-03NoNoCurrent
42192-331-304219203313030 TABLET in 1 BOTTLE (42192-331-30) 30 tablet2025-03-03NoNoCurrent
42192-331-904219203319090 TABLET in 1 BOTTLE (42192-331-90) 90 tablet2025-12-01NoNoCurrent