FDA.reportPublic FDA data

NP Thyroid 15

Product NDC
42192-327
11-digit product format
421920327
Labeler code
42192
Product ID
42192-327_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
2016-11-16
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NP Thyroid 15
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIOTHYRONINE9.5 ug/1
LEVOTHYROXINE2.25 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 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
208545Internal RxNorm lookup
313387Internal RxNorm lookup
313391Internal RxNorm lookup
313393Internal RxNorm lookup
314267Internal RxNorm lookup
1724437Internal RxNorm lookup
1724439Internal RxNorm lookup
1724481Internal RxNorm lookup
1855086Internal RxNorm lookup
1923809Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a3ff93ad-86ed-4324-ae86-7e7ed3a49db8Available 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
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
42192-327-01NP Thyroid 15100 in 1 BOTTLETABLET10018
42192-327-30NP Thyroid 1530 in 1 BOTTLETABLET3018
42192-327-90NP Thyroid 1590 in 1 BOTTLETABLET9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-327-01EA - Each42192-327a7d2fc8f-ef92-480f-9bba-b7472766855312016-11-08
42192-327-30EA - Each42192-327021352cb-a459-4be9-8f7d-d5aad37007e312025-05-14
42192-327-90EA - Each42192-327fc95a06a-33c3-4a5e-a244-d677f27851ac12026-05-22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-327NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE) TABLET [ACELLA PHARMACEUTICALS, LLC]14Current NDC, Legacy NDC, 3 package rows20250309_a3ff93ad-86ed-4324-ae86-7e7ed3a49db8.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
NP Thyroid 15LEVOTHYROXINE, LIOTHYRONINEAcella Pharmaceuticals, LLCa3ff93ad-86ed-4324-ae86-7e7ed3a49db82026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 42192-327

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
1855086NP Thyroid 15 MG Oral TabletPSN174dd249-9ab6-1602-e063-6294a90ae7791
1855086NP Thyroid 15 MG Oral TabletPSN3c25a33b-4433-eb91-e063-6394a90a6ffe1
1855086NP Thyroid 15 MG Oral TabletPSN3c2688e4-e703-4213-e063-6394a90a70571
1855086NP Thyroid 15 MG Oral TabletPSN3c270b9a-05c2-6a30-e063-6394a90a28441
314267thyroid 15 MG (1/4 grain) Oral TabletPSN3c270b9a-05c2-6a30-e063-6394a90a28441
314267thyroid 15 MG (1/4 grain) Oral TabletPSN174dd249-9ab6-1602-e063-6294a90ae7791
314267thyroid 15 MG (1/4 grain) Oral TabletPSN3c25a33b-4433-eb91-e063-6394a90a6ffe1
314267thyroid 15 MG (1/4 grain) Oral TabletPSN3c2688e4-e703-4213-e063-6394a90a70571
1855086thyroid (USP) 15 MG Oral Tablet [NP Thyroid]SBD3c270b9a-05c2-6a30-e063-6394a90a28441
1855086thyroid (USP) 15 MG Oral Tablet [NP Thyroid]SBD3c2688e4-e703-4213-e063-6394a90a70571
1855086thyroid (USP) 15 MG Oral Tablet [NP Thyroid]SBD174dd249-9ab6-1602-e063-6294a90ae7791
1855086thyroid (USP) 15 MG Oral Tablet [NP Thyroid]SBD3c25a33b-4433-eb91-e063-6394a90a6ffe1
314267thyroid (USP) 15 MG Oral TabletSCD3c2688e4-e703-4213-e063-6394a90a70571
314267thyroid (USP) 15 MG Oral TabletSCD3c25a33b-4433-eb91-e063-6394a90a6ffe1
314267thyroid (USP) 15 MG Oral TabletSCD174dd249-9ab6-1602-e063-6294a90ae7791
314267thyroid (USP) 15 MG Oral TabletSCD3c270b9a-05c2-6a30-e063-6394a90a28441
314267levothyroxine sodium 9.5 MCG / liothyronine sodium 2.25 MCG Oral TabletSY3c2688e4-e703-4213-e063-6394a90a70571
314267levothyroxine sodium 9.5 MCG / liothyronine sodium 2.25 MCG Oral TabletSY174dd249-9ab6-1602-e063-6294a90ae7791
314267levothyroxine sodium 9.5 MCG / liothyronine sodium 2.25 MCG Oral TabletSY3c270b9a-05c2-6a30-e063-6394a90a28441
314267levothyroxine sodium 9.5 MCG / liothyronine sodium 2.25 MCG Oral TabletSY3c25a33b-4433-eb91-e063-6394a90a6ffe1
1855086NP Thyroid (levothyroxine sodium 9.5 MCG / liothyronine sodium 2.25 MCG) Oral TabletSY174dd249-9ab6-1602-e063-6294a90ae7791
1855086NP Thyroid (levothyroxine sodium 9.5 MCG / liothyronine sodium 2.25 MCG) Oral TabletSY3c270b9a-05c2-6a30-e063-6394a90a28441
1855086NP Thyroid (levothyroxine sodium 9.5 MCG / liothyronine sodium 2.25 MCG) Oral TabletSY3c25a33b-4433-eb91-e063-6394a90a6ffe1
1855086NP Thyroid (levothyroxine sodium 9.5 MCG / liothyronine sodium 2.25 MCG) Oral TabletSY3c2688e4-e703-4213-e063-6394a90a70571
1855086NP Thyroid 15 MG Oral TabletSY3c25a33b-4433-eb91-e063-6394a90a6ffe1
1855086NP Thyroid 15 MG Oral TabletSY3c270b9a-05c2-6a30-e063-6394a90a28441
1855086NP Thyroid 15 MG Oral TabletSY174dd249-9ab6-1602-e063-6294a90ae7791
1855086NP Thyroid 15 MG Oral TabletSY3c2688e4-e703-4213-e063-6394a90a70571
314267thyroid (USP) 1/4 grain Oral TabletSY3c25a33b-4433-eb91-e063-6394a90a6ffe1
314267thyroid (USP) 1/4 grain Oral TabletSY3c270b9a-05c2-6a30-e063-6394a90a28441
314267thyroid (USP) 1/4 grain Oral TabletSY3c2688e4-e703-4213-e063-6394a90a70571
314267thyroid (USP) 1/4 grain Oral TabletSY174dd249-9ab6-1602-e063-6294a90ae7791

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42192-327-0142192032701100 TABLET in 1 BOTTLE (42192-327-01) 100 tablet2016-11-160000-00-00NoNoCurrent
42192-327-304219203273030 TABLET in 1 BOTTLE (42192-327-30) 30 tablet2025-03-03NoNoCurrent
42192-327-904219203279090 TABLET in 1 BOTTLE (42192-327-90) 90 tablet2025-12-01NoNoCurrent