FDA.reportPublic FDA data

Levothyroxine sodium

Product NDC
16729-448
11-digit product format
167290448
Labeler code
16729
Product ID
16729-448_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
2020-11-25
Substance
LEVOTHYROXINE SODIUM
Active strength
50 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 SODIUM50 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
16729-448-15Levothyroxine sodium90 in 1 BOTTLETABLET9011
16729-448-17Levothyroxine sodium1000 in 1 BOTTLETABLET100011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-448LEVOTHYROXINE 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
966221levothyroxine sodium 50 MCG Oral TabletPSNf347d92a-7726-4165-bc3c-f5b37ec86f9f105
966221levothyroxine sodium 0.05 MG Oral TabletSCDf347d92a-7726-4165-bc3c-f5b37ec86f9f105
966221levothyroxine sodium 50 MCG Oral TabletSYf347d92a-7726-4165-bc3c-f5b37ec86f9f105
966221levothyroxine sodium 50 MCG Oral TabletPSN70a9bb5c-2259-405e-8d89-cc1db8c7074314
966221levothyroxine sodium 0.05 MG Oral TabletSCD70a9bb5c-2259-405e-8d89-cc1db8c7074314
966221levothyroxine sodium 50 MCG Oral TabletSY70a9bb5c-2259-405e-8d89-cc1db8c7074314
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
966221levothyroxine sodium 50 MCG Oral TabletPSN0cffbc96-7a02-4538-9966-b69249be6eb26
966221levothyroxine sodium 0.05 MG Oral TabletSCD0cffbc96-7a02-4538-9966-b69249be6eb26
966221levothyroxine sodium 50 MCG Oral TabletSY0cffbc96-7a02-4538-9966-b69249be6eb26
966221levothyroxine sodium 50 MCG Oral TabletPSNeb149423-070f-49ae-ab18-5afee09d06fb5
966221levothyroxine sodium 0.05 MG Oral TabletSCDeb149423-070f-49ae-ab18-5afee09d06fb5
966221levothyroxine sodium 50 MCG Oral TabletSYeb149423-070f-49ae-ab18-5afee09d06fb5
966221levothyroxine sodium 50 MCG Oral TabletPSNdb998119-a293-3568-e053-2995a90ac47a4
966221levothyroxine sodium 50 MCG Oral TabletPSNc7d5b71b-e983-4b1a-bfc2-d2343cf8668c4
966221levothyroxine sodium 0.05 MG Oral TabletSCDdb998119-a293-3568-e053-2995a90ac47a4
966221levothyroxine sodium 0.05 MG Oral TabletSCDc7d5b71b-e983-4b1a-bfc2-d2343cf8668c4
966221levothyroxine sodium 50 MCG Oral TabletSYdb998119-a293-3568-e053-2995a90ac47a4
966221levothyroxine sodium 50 MCG Oral TabletSYc7d5b71b-e983-4b1a-bfc2-d2343cf8668c4
966221levothyroxine sodium 50 MCG Oral TabletPSN60a0bc29-4283-4ae9-9173-5caf9266f7233
966221levothyroxine sodium 0.05 MG Oral TabletSCD60a0bc29-4283-4ae9-9173-5caf9266f7233
966221levothyroxine sodium 50 MCG Oral TabletSY60a0bc29-4283-4ae9-9173-5caf9266f7233
966221levothyroxine sodium 50 MCG Oral TabletPSNfa2ad501-8c61-b484-e053-6394a90ab34d2
966221levothyroxine sodium 50 MCG Oral TabletPSN329b6eb2-4fa3-41f6-a6ff-96d94b7a65bf2
966221levothyroxine sodium 0.05 MG Oral TabletSCDfa2ad501-8c61-b484-e053-6394a90ab34d2
966221levothyroxine sodium 0.05 MG Oral TabletSCD329b6eb2-4fa3-41f6-a6ff-96d94b7a65bf2
966221levothyroxine sodium 50 MCG Oral TabletSYfa2ad501-8c61-b484-e053-6394a90ab34d2
966221levothyroxine sodium 50 MCG Oral TabletSY329b6eb2-4fa3-41f6-a6ff-96d94b7a65bf2
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 TabletPSN42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
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 TabletPSNc831c214-471b-36c5-e053-2a95a90a4f011
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
966221levothyroxine sodium 0.05 MG Oral TabletSCDc831c214-471b-36c5-e053-2a95a90a4f011
966222levothyroxine sodium 0.075 MG Oral TabletSCD42a26f8a-dc67-42e4-abb0-d2602afb1b7d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-448-151672904481590 TABLET in 1 BOTTLE (16729-448-15) 90 tablet2020-12-030000-00-00NoNoCurrent
16729-448-17167290448171000 TABLET in 1 BOTTLE (16729-448-17) 1000 tablet2020-11-250000-00-00NoNoCurrent