FDA.reportPublic FDA data

NP Thyroid 120

Product NDC
42192-328
11-digit product format
421920328
Labeler code
42192
Product ID
42192-328_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
2017-06-12
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
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NP Thyroid 15LEVOTHYROXINE, LIOTHYRONINEAcella Pharmaceuticals, LLCa3ff93ad-86ed-4324-ae86-7e7ed3a49db82026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier

Boxed warning cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

boxed warning

Drugs with thyroid hormone activity, alone or together with other therapeutic agents, have been used for the treatment of obesity. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS Drugs with thyroid hormone activity, alone or together with other therapeutic agents, have been used for the treatment of obesity. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects. The use of thyroid hormones in the therapy of obesity, alone or combined with other drugs, is unjustified and has been shown to be ineffective. Neither is their use justified for the treatment of male or female infertility unless this condition is accompanied by hypothyroidism.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

ADVERSE REACTIONS Adverse reactions other than those indicative of hyperthyroidism because of therapeutic overdosage, either initially or during the maintenance period, are rare (See OVERDOSAGE).

Additional Listing Data#

Finished product
Yes
Brand name base
NP Thyroid 120
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE76 ug/1
LIOTHYRONINE18 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ51BO43MG4, 06LU7C9H1V
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
42192-328-01NP Thyroid 120100 in 1 BOTTLETABLET10018
42192-328-30NP Thyroid 12030 in 1 BOTTLETABLET3018
42192-328-90NP Thyroid 12090 in 1 BOTTLETABLET9018
42192-328-01NP Thyroid 120100 in 1 BOTTLETABLET10012
42192-328-30NP Thyroid 12030 in 1 BOTTLETABLET3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-328-01EA - Each42192-32848713647-41f2-4c54-af0a-4aef2db9b16212017-06-15
42192-328-30EA - Each42192-328ea4ca27d-7545-430b-a88a-d8b477bc1ec512025-05-14
42192-328-90EA - Each42192-328738ce52b-d988-49d4-85a5-0ecbfb9f408112026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-328NP THYROID 120 (LEVOTHYROXINE, LIOTHYRONINE) TABLET [ACELLA PHARMACEUTICALS, LLC]11Current NDC, Legacy NDC, 2 package rows20250309_00046231-8fab-44a0-b986-9a9dd450881d.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
1923809NP Thyroid 120 MG Oral TabletPSN3b9cc131-f2ff-59e2-e063-6294a90ac21714
208545thyroid 120 MG (2 grain) Oral TabletPSN3b9cc131-f2ff-59e2-e063-6294a90ac21714
1923809thyroid (USP) 120 MG Oral Tablet [NP Thyroid]SBD3b9cc131-f2ff-59e2-e063-6294a90ac21714
208545thyroid (USP) 120 MG Oral TabletSCD3b9cc131-f2ff-59e2-e063-6294a90ac21714
208545levothyroxine sodium 76 MCG / liothyronine sodium 18 MCG Oral TabletSY3b9cc131-f2ff-59e2-e063-6294a90ac21714
1923809NP Thyroid (levothyroxine sodium 76 MCG / liothyronine sodium 18 MCG) Oral TabletSY3b9cc131-f2ff-59e2-e063-6294a90ac21714
1923809NP Thyroid 120 MG Oral TabletSY3b9cc131-f2ff-59e2-e063-6294a90ac21714
1923809NP Thyroid 2 grains Oral TabletSY3b9cc131-f2ff-59e2-e063-6294a90ac21714
208545thyroid (USP) 2 grain Oral TabletSY3b9cc131-f2ff-59e2-e063-6294a90ac21714
1923809NP Thyroid 120 MG Oral TabletPSN00046231-8fab-44a0-b986-9a9dd450881d12
208545thyroid 120 MG (2 grain) Oral TabletPSN00046231-8fab-44a0-b986-9a9dd450881d12
1923809thyroid (USP) 120 MG Oral Tablet [NP Thyroid]SBD00046231-8fab-44a0-b986-9a9dd450881d12
208545thyroid (USP) 120 MG Oral TabletSCD00046231-8fab-44a0-b986-9a9dd450881d12
208545levothyroxine sodium 76 MCG / liothyronine sodium 18 MCG Oral TabletSY00046231-8fab-44a0-b986-9a9dd450881d12
1923809NP Thyroid (levothyroxine sodium 76 MCG / liothyronine sodium 18 MCG) Oral TabletSY00046231-8fab-44a0-b986-9a9dd450881d12
1923809NP Thyroid 120 MG Oral TabletSY00046231-8fab-44a0-b986-9a9dd450881d12
1923809NP Thyroid 2 grains Oral TabletSY00046231-8fab-44a0-b986-9a9dd450881d12
208545thyroid (USP) 2 grain Oral TabletSY00046231-8fab-44a0-b986-9a9dd450881d12
1923809NP Thyroid 120 MG Oral TabletPSNf5fefea5-51ab-40d8-aefc-3563292534671
1923809NP Thyroid 120 MG Oral TabletPSN19b66f94-a3e1-4f73-ad9b-726036d2cb0b1
1923809NP Thyroid 120 MG Oral TabletPSN3c0015dc-e708-6823-e063-6394a90a0ad91
1923809NP Thyroid 120 MG Oral TabletPSN3c008803-7bbd-9f39-e063-6394a90afa581
208545thyroid 120 MG (2 grain) Oral TabletPSNf5fefea5-51ab-40d8-aefc-3563292534671
208545thyroid 120 MG (2 grain) Oral TabletPSN3c008803-7bbd-9f39-e063-6394a90afa581
208545thyroid 120 MG (2 grain) Oral TabletPSN19b66f94-a3e1-4f73-ad9b-726036d2cb0b1
208545thyroid 120 MG (2 grain) Oral TabletPSN3c0015dc-e708-6823-e063-6394a90a0ad91
1923809thyroid (USP) 120 MG Oral Tablet [NP Thyroid]SBD19b66f94-a3e1-4f73-ad9b-726036d2cb0b1
1923809thyroid (USP) 120 MG Oral Tablet [NP Thyroid]SBDf5fefea5-51ab-40d8-aefc-3563292534671
1923809thyroid (USP) 120 MG Oral Tablet [NP Thyroid]SBD3c0015dc-e708-6823-e063-6394a90a0ad91
1923809thyroid (USP) 120 MG Oral Tablet [NP Thyroid]SBD3c008803-7bbd-9f39-e063-6394a90afa581
208545thyroid (USP) 120 MG Oral TabletSCD3c0015dc-e708-6823-e063-6394a90a0ad91
208545thyroid (USP) 120 MG Oral TabletSCDf5fefea5-51ab-40d8-aefc-3563292534671
208545thyroid (USP) 120 MG Oral TabletSCD3c008803-7bbd-9f39-e063-6394a90afa581
208545thyroid (USP) 120 MG Oral TabletSCD19b66f94-a3e1-4f73-ad9b-726036d2cb0b1
208545levothyroxine sodium 76 MCG / liothyronine sodium 18 MCG Oral TabletSY19b66f94-a3e1-4f73-ad9b-726036d2cb0b1
208545levothyroxine sodium 76 MCG / liothyronine sodium 18 MCG Oral TabletSY3c008803-7bbd-9f39-e063-6394a90afa581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42192-328-0142192032801100 TABLET in 1 BOTTLE (42192-328-01) 100 tablet2017-06-120000-00-00NoNoCurrent
42192-328-304219203283030 TABLET in 1 BOTTLE (42192-328-30) 30 tablet2025-03-03NoNoCurrent
42192-328-904219203289090 TABLET in 1 BOTTLE (42192-328-90) 90 tablet2025-12-01NoNoCurrent