FDA.reportPublic FDA data

Levothyroxine sodium

Product NDC
16729-453
11-digit product format
167290453
Labeler code
16729
Product ID
16729-453_415fc774-31a5-124f-e063-6294a90a0e46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA212399
Marketing category
ANDA
Marketing start
2020-12-03
Substance
LEVOTHYROXINE SODIUM
Active strength
125 ug/1
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levothyroxine sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM125 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui892246, 892251, 892255, 966220, 966221, 966222, 966224, 966225, 966248, 966249, 966253, 966270

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
97c252d3-9bb8-4530-bb44-9824dc7cf556Product name620250729
6c43b71c-35e6-4db3-ba24-c6ef42ff7003Product name320240207
890fd4bf-1a80-42b7-be1b-2d0259d5f0c8Product name520240207
c8ad26bf-af73-460b-b74e-1eff16cc4f9fProduct name520240207
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
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
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-453-15Levothyroxine sodium90 in 1 BOTTLETABLET9011
16729-453-17Levothyroxine sodium1000 in 1 BOTTLETABLET100011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-453LEVOTHYROXINE SODIUM TABLET [ACCORD HEALTHCARE INC.]10Current NDC, Legacy NDC, 2 package rows20241108_a6233381-3043-4e9a-aaa6-a6b105e5142b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966224levothyroxine sodium 125 MCG Oral TabletPSN893f9d10-7ce5-4ae6-8f03-dfde35ca6c30104
966224levothyroxine sodium 0.125 MG Oral TabletSCD893f9d10-7ce5-4ae6-8f03-dfde35ca6c30104
966224levothyroxine sodium 125 MCG Oral TabletSY893f9d10-7ce5-4ae6-8f03-dfde35ca6c30104
892246levothyroxine sodium 100 MCG Oral TabletPSNa6233381-3043-4e9a-aaa6-a6b105e5142b11
966248levothyroxine sodium 112 MCG Oral TabletPSNa6233381-3043-4e9a-aaa6-a6b105e5142b11
966224levothyroxine sodium 125 MCG Oral TabletPSNa6233381-3043-4e9a-aaa6-a6b105e5142b11
966270levothyroxine sodium 137 MCG Oral TabletPSNa6233381-3043-4e9a-aaa6-a6b105e5142b11
966225levothyroxine sodium 150 MCG Oral TabletPSNa6233381-3043-4e9a-aaa6-a6b105e5142b11
966249levothyroxine sodium 175 MCG Oral TabletPSNa6233381-3043-4e9a-aaa6-a6b105e5142b11
892251levothyroxine sodium 200 MCG Oral TabletPSNa6233381-3043-4e9a-aaa6-a6b105e5142b11
966220levothyroxine sodium 25 MCG Oral TabletPSNa6233381-3043-4e9a-aaa6-a6b105e5142b11
892255levothyroxine sodium 300 MCG Oral TabletPSNa6233381-3043-4e9a-aaa6-a6b105e5142b11
966221levothyroxine sodium 50 MCG Oral TabletPSNa6233381-3043-4e9a-aaa6-a6b105e5142b11
966222levothyroxine sodium 75 MCG Oral TabletPSNa6233381-3043-4e9a-aaa6-a6b105e5142b11
966253levothyroxine sodium 88 MCG Oral TabletPSNa6233381-3043-4e9a-aaa6-a6b105e5142b11
966220levothyroxine sodium 0.025 MG Oral TabletSCDa6233381-3043-4e9a-aaa6-a6b105e5142b11
966221levothyroxine sodium 0.05 MG Oral TabletSCDa6233381-3043-4e9a-aaa6-a6b105e5142b11
966222levothyroxine sodium 0.075 MG Oral TabletSCDa6233381-3043-4e9a-aaa6-a6b105e5142b11
966253levothyroxine sodium 0.088 MG Oral TabletSCDa6233381-3043-4e9a-aaa6-a6b105e5142b11
892246levothyroxine sodium 0.1 MG Oral TabletSCDa6233381-3043-4e9a-aaa6-a6b105e5142b11
966248levothyroxine sodium 0.112 MG Oral TabletSCDa6233381-3043-4e9a-aaa6-a6b105e5142b11
966224levothyroxine sodium 0.125 MG Oral TabletSCDa6233381-3043-4e9a-aaa6-a6b105e5142b11
966270levothyroxine sodium 0.137 MG Oral TabletSCDa6233381-3043-4e9a-aaa6-a6b105e5142b11
966225levothyroxine sodium 0.15 MG Oral TabletSCDa6233381-3043-4e9a-aaa6-a6b105e5142b11
966249levothyroxine sodium 0.175 MG Oral TabletSCDa6233381-3043-4e9a-aaa6-a6b105e5142b11
892251levothyroxine sodium 0.2 MG Oral TabletSCDa6233381-3043-4e9a-aaa6-a6b105e5142b11
892255levothyroxine sodium 0.3 MG Oral TabletSCDa6233381-3043-4e9a-aaa6-a6b105e5142b11
892246levothyroxine sodium 100 MCG Oral TabletSYa6233381-3043-4e9a-aaa6-a6b105e5142b11
966248levothyroxine sodium 112 MCG Oral TabletSYa6233381-3043-4e9a-aaa6-a6b105e5142b11
966224levothyroxine sodium 125 MCG Oral TabletSYa6233381-3043-4e9a-aaa6-a6b105e5142b11
966270levothyroxine sodium 137 MCG Oral TabletSYa6233381-3043-4e9a-aaa6-a6b105e5142b11
966225levothyroxine sodium 150 MCG Oral TabletSYa6233381-3043-4e9a-aaa6-a6b105e5142b11
966249levothyroxine sodium 175 MCG Oral TabletSYa6233381-3043-4e9a-aaa6-a6b105e5142b11
892251levothyroxine sodium 200 MCG Oral TabletSYa6233381-3043-4e9a-aaa6-a6b105e5142b11
966220levothyroxine sodium 25 MCG Oral TabletSYa6233381-3043-4e9a-aaa6-a6b105e5142b11
892255levothyroxine sodium 300 MCG Oral TabletSYa6233381-3043-4e9a-aaa6-a6b105e5142b11
966221levothyroxine sodium 50 MCG Oral TabletSYa6233381-3043-4e9a-aaa6-a6b105e5142b11
966222levothyroxine sodium 75 MCG Oral TabletSYa6233381-3043-4e9a-aaa6-a6b105e5142b11
966253levothyroxine sodium 88 MCG Oral TabletSYa6233381-3043-4e9a-aaa6-a6b105e5142b11
966224levothyroxine sodium 125 MCG Oral TabletPSN70853a82-ba3b-4663-9f78-6791ca72ba9f9
966224levothyroxine sodium 0.125 MG Oral TabletSCD70853a82-ba3b-4663-9f78-6791ca72ba9f9
966224levothyroxine sodium 125 MCG Oral TabletSY70853a82-ba3b-4663-9f78-6791ca72ba9f9
966248levothyroxine sodium 112 MCG Oral TabletPSN83854522-f22e-491f-8392-c8b1f94417607
966224levothyroxine sodium 125 MCG Oral TabletPSNa0fa8fa5-d3bd-4e52-9ec5-5fb84702826d7
966224levothyroxine sodium 125 MCG Oral TabletPSN83854522-f22e-491f-8392-c8b1f94417607
966253levothyroxine sodium 88 MCG Oral TabletPSN83854522-f22e-491f-8392-c8b1f94417607
966253levothyroxine sodium 0.088 MG Oral TabletSCD83854522-f22e-491f-8392-c8b1f94417607
966248levothyroxine sodium 0.112 MG Oral TabletSCD83854522-f22e-491f-8392-c8b1f94417607
966224levothyroxine sodium 0.125 MG Oral TabletSCDa0fa8fa5-d3bd-4e52-9ec5-5fb84702826d7
966224levothyroxine sodium 0.125 MG Oral TabletSCD83854522-f22e-491f-8392-c8b1f94417607
966248levothyroxine sodium 112 MCG Oral TabletSY83854522-f22e-491f-8392-c8b1f94417607
966224levothyroxine sodium 125 MCG Oral TabletSY83854522-f22e-491f-8392-c8b1f94417607
966224levothyroxine sodium 125 MCG Oral TabletSYa0fa8fa5-d3bd-4e52-9ec5-5fb84702826d7
966253levothyroxine sodium 88 MCG Oral TabletSY83854522-f22e-491f-8392-c8b1f94417607
966224levothyroxine sodium 125 MCG Oral TabletPSNcba6bb77-2140-6cba-e053-2995a90aa1b63
966224levothyroxine sodium 0.125 MG Oral TabletSCDcba6bb77-2140-6cba-e053-2995a90aa1b63
966224levothyroxine sodium 125 MCG Oral TabletSYcba6bb77-2140-6cba-e053-2995a90aa1b63
892246levothyroxine sodium 100 MCG Oral TabletPSN42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966248levothyroxine sodium 112 MCG Oral TabletPSN42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966224levothyroxine sodium 125 MCG Oral TabletPSN7fd988be-ab3d-406d-a55d-1e5a8a2101cc1
966224levothyroxine sodium 125 MCG Oral TabletPSN42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966224levothyroxine sodium 125 MCG Oral TabletPSN2f129a3d-f3e6-45b2-9704-3ad171cbd8a51
966270levothyroxine sodium 137 MCG Oral TabletPSN42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966225levothyroxine sodium 150 MCG Oral TabletPSN42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966249levothyroxine sodium 175 MCG Oral TabletPSN42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
892251levothyroxine sodium 200 MCG Oral TabletPSN42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966220levothyroxine sodium 25 MCG Oral TabletPSN42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
892255levothyroxine sodium 300 MCG Oral TabletPSN42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966221levothyroxine sodium 50 MCG Oral TabletPSN42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966222levothyroxine sodium 75 MCG Oral TabletPSN42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966253levothyroxine sodium 88 MCG Oral TabletPSN42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966220levothyroxine sodium 0.025 MG Oral TabletSCD42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966221levothyroxine sodium 0.05 MG Oral TabletSCD42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966222levothyroxine sodium 0.075 MG Oral TabletSCD42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966253levothyroxine sodium 0.088 MG Oral TabletSCD42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
892246levothyroxine sodium 0.1 MG Oral TabletSCD42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966248levothyroxine sodium 0.112 MG Oral TabletSCD42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966224levothyroxine sodium 0.125 MG Oral TabletSCD42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966224levothyroxine sodium 0.125 MG Oral TabletSCD7fd988be-ab3d-406d-a55d-1e5a8a2101cc1
966224levothyroxine sodium 0.125 MG Oral TabletSCD2f129a3d-f3e6-45b2-9704-3ad171cbd8a51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-453-151672904531590 TABLET in 1 BOTTLE (16729-453-15) 90 tablet2020-12-030000-00-00NoNoCurrent
16729-453-17167290453171000 TABLET in 1 BOTTLE (16729-453-17) 1000 tablet2020-12-030000-00-00NoNoCurrent