FDA.reportPublic FDA data

Niva Thyroid

Product NDC
75834-314
11-digit product format
758340314
Labeler code
75834
Product ID
75834-314_1cce3de8-0aa9-4f05-9104-a84b7d91dd68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
thyroid, porcine
Dosage form
TABLET
Route
ORAL
Labeler
Nivagen Pharmaceuticals, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-07-24
Substance
THYROID
Active strength
120 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
THYROID120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6RV024OAUQ
Rxcui198278, 208545, 313385, 313387, 313391, 313393, 314267, 315235, 2642816, 2642818, 2642820, 2642822, 2642824, 2642826, 2642828, 2642830

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
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
75834-314-01Niva Thyroid100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-314-01EA - Each75834-31422ea43d1-ad14-44e0-93db-8f5fbf26f77d12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-314NIVA THYROID (THYROID, PORCINE) TABLET [NIVAGEN PHARMACEUTICALS, INC.]3Current NDC, 1 package rows20231104_eae7789a-d85d-4b04-a680-e688a371ebee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2642816Niva Thyroid 120 MG (2 grain) Oral TabletPSNeae7789a-d85d-4b04-a680-e688a371ebee3
2642818Niva Thyroid 15 MG (1/4 grain) Oral TabletPSNeae7789a-d85d-4b04-a680-e688a371ebee3
2642820Niva Thyroid 180 MG (3 grain) Oral TabletPSNeae7789a-d85d-4b04-a680-e688a371ebee3
2642822Niva Thyroid 240 MG (4 grain) Oral TabletPSNeae7789a-d85d-4b04-a680-e688a371ebee3
2642824Niva Thyroid 30 MG (1/2 grain) Oral TabletPSNeae7789a-d85d-4b04-a680-e688a371ebee3
2642826Niva Thyroid 300 MG (5 grain) Oral TabletPSNeae7789a-d85d-4b04-a680-e688a371ebee3
2642828Niva Thyroid 60 MG (1 grain) Oral TabletPSNeae7789a-d85d-4b04-a680-e688a371ebee3
2642830Niva Thyroid 90 MG (1 1/2 grain) Oral TabletPSNeae7789a-d85d-4b04-a680-e688a371ebee3
208545thyroid 120 MG (2 grain) Oral TabletPSNeae7789a-d85d-4b04-a680-e688a371ebee3
314267thyroid 15 MG (1/4 grain) Oral TabletPSNeae7789a-d85d-4b04-a680-e688a371ebee3
198278thyroid 180 MG (3 grain) Oral TabletPSNeae7789a-d85d-4b04-a680-e688a371ebee3
313385thyroid 240 MG (4 grain) Oral TabletPSNeae7789a-d85d-4b04-a680-e688a371ebee3
313387thyroid 30 MG (1/2 grain) Oral TabletPSNeae7789a-d85d-4b04-a680-e688a371ebee3
315235thyroid 300 MG (5 grain) Oral TabletPSNeae7789a-d85d-4b04-a680-e688a371ebee3
313391thyroid 60 MG (1 grain) Oral TabletPSNeae7789a-d85d-4b04-a680-e688a371ebee3
313393thyroid 90 MG (1 1/2 grain) Oral TabletPSNeae7789a-d85d-4b04-a680-e688a371ebee3
2642816thyroid (USP) 120 MG Oral Tablet [Niva Thyroid]SBDeae7789a-d85d-4b04-a680-e688a371ebee3
2642818thyroid (USP) 15 MG Oral Tablet [Niva Thyroid]SBDeae7789a-d85d-4b04-a680-e688a371ebee3
2642820thyroid (USP) 180 MG Oral Tablet [Niva Thyroid]SBDeae7789a-d85d-4b04-a680-e688a371ebee3
2642822thyroid (USP) 240 MG Oral Tablet [Niva Thyroid]SBDeae7789a-d85d-4b04-a680-e688a371ebee3
2642824thyroid (USP) 30 MG Oral Tablet [Niva Thyroid]SBDeae7789a-d85d-4b04-a680-e688a371ebee3
2642826thyroid (USP) 300 MG Oral Tablet [Niva Thyroid]SBDeae7789a-d85d-4b04-a680-e688a371ebee3
2642828thyroid (USP) 60 MG Oral Tablet [Niva Thyroid]SBDeae7789a-d85d-4b04-a680-e688a371ebee3
2642830thyroid (USP) 90 MG Oral Tablet [Niva Thyroid]SBDeae7789a-d85d-4b04-a680-e688a371ebee3
208545thyroid (USP) 120 MG Oral TabletSCDeae7789a-d85d-4b04-a680-e688a371ebee3
314267thyroid (USP) 15 MG Oral TabletSCDeae7789a-d85d-4b04-a680-e688a371ebee3
198278thyroid (USP) 180 MG Oral TabletSCDeae7789a-d85d-4b04-a680-e688a371ebee3
313385thyroid (USP) 240 MG Oral TabletSCDeae7789a-d85d-4b04-a680-e688a371ebee3
313387thyroid (USP) 30 MG Oral TabletSCDeae7789a-d85d-4b04-a680-e688a371ebee3
315235thyroid (USP) 300 MG Oral TabletSCDeae7789a-d85d-4b04-a680-e688a371ebee3
313391thyroid (USP) 60 MG Oral TabletSCDeae7789a-d85d-4b04-a680-e688a371ebee3
313393thyroid (USP) 90 MG Oral TabletSCDeae7789a-d85d-4b04-a680-e688a371ebee3
198278levothyroxine sodium 114 MCG / liothyronine sodium 27 MCG Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
313385levothyroxine sodium 152 MCG / liothyronine sodium 36 MCG Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
313387levothyroxine sodium 19 MCG / liothyronine sodium 4.5 MCG Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
315235levothyroxine sodium 190 MCG / liothyronine sodium 45 MCG Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
313391levothyroxine sodium 38 MCG / liothyronine sodium 9 MCG Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
313393levothyroxine sodium 57 MCG / liothyronine sodium 13.5 MCG Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
208545levothyroxine sodium 76 MCG / liothyronine sodium 18 MCG Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
314267levothyroxine sodium 9.5 MCG / liothyronine sodium 2.25 MCG Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
2642820Niva Thyroid (levothyroxine sodium 114 MCG / liothyronine sodium 27 MCG) Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
2642822Niva Thyroid (levothyroxine sodium 152 MCG / liothyronine sodium 36 MCG) Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
2642824Niva Thyroid (levothyroxine sodium 19 MCG / liothyronine sodium 4.5 MCG) Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
2642826Niva Thyroid (levothyroxine sodium 190 MCG / liothyronine sodium 45 MCG) Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
2642828Niva Thyroid (levothyroxine sodium 38 MCG / liothyronine sodium 9 MCG) Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
2642830Niva Thyroid (levothyroxine sodium 57 MCG / liothyronine sodium 13.5 MCG) Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
2642816Niva Thyroid (levothyroxine sodium 76 MCG / liothyronine sodium 18 MCG) Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
2642818Niva Thyroid (levothyroxine sodium 9.5 MCG / liothyronine sodium 2.25 MCG) Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
2642830Niva Thyroid 1 1/2 grain Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
2642828Niva Thyroid 1 grain Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
2642824Niva Thyroid 1/2 grain Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
2642818Niva Thyroid 1/4 grain Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
2642816Niva Thyroid 2 grain Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
2642820Niva Thyroid 3 grain Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
2642822Niva Thyroid 4 grain Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
2642826Niva Thyroid 5 grain Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
313393thyroid (USP) 1 1/2 grain Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
313391thyroid (USP) 1 grain Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
313387thyroid (USP) 1/2 grain Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
314267thyroid (USP) 1/4 grain Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
208545thyroid (USP) 2 grain Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
198278thyroid (USP) 3 grain Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
313385thyroid (USP) 4 grain Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3
315235thyroid (USP) 5 grain Oral TabletSYeae7789a-d85d-4b04-a680-e688a371ebee3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75834-314-0175834031401100 TABLET in 1 BOTTLE (75834-314-01) 100 tablet2023-07-24NoNoCurrent