Levothyroxine Sodium

Product NDC
63323-895
Requested package NDC
63323-895-10
11-digit product format
633230895
Labeler code
63323
Product ID
63323-895_09cdd46f-eae9-4faa-b3b3-67fcd71b62ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
NDA210632
Marketing category
NDA
Marketing start
2018-05-29
Substance
LEVOTHYROXINE SODIUM
Active strength
100 ug/mL
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N210632-001LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM100MCG/5ML (20MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-11
N210632-002LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM200MCG/5ML (40MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-11
N210632-003LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM500MCG/5ML (100MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-11

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N210632-001103986692036-12-01Drug product2019-09-13
N210632-001111351902036-12-01Drug product2021-10-07
N210632-001126362702036-12-01Drug product2026-06-18
N210632-00197823762036-12-01Drug product2019-06-11
N210632-002103986692036-12-01Drug product2019-09-13
N210632-002111351902036-12-01Drug product2021-10-07
N210632-002126362702036-12-01Drug product2026-06-18
N210632-00297823762036-12-01Drug product2019-06-11
N210632-003103986692036-12-01Drug product2019-09-13
N210632-003111351902036-12-01Drug product2021-10-07
N210632-003126362702036-12-01Drug product2026-06-18
N210632-00397823762036-12-01Drug product2019-06-11

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N210632-001LEVOTHYROXINE SODIUM100MCG/5ML (20MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210632-002LEVOTHYROXINE SODIUM200MCG/5ML (40MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210632-003LEVOTHYROXINE SODIUM500MCG/5ML (100MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210632-001LEVOTHYROXINE SODIUM100MCG/5ML (20MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210632-002LEVOTHYROXINE SODIUM200MCG/5ML (40MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210632-003LEVOTHYROXINE SODIUM500MCG/5ML (100MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N210632-001LEVOTHYROXINE SODIUM100MCG/5ML (20MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210632-002LEVOTHYROXINE SODIUM200MCG/5ML (40MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210632-003LEVOTHYROXINE SODIUM500MCG/5ML (100MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210632-001LEVOTHYROXINE SODIUM100MCG/5ML (20MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210632-002LEVOTHYROXINE SODIUM200MCG/5ML (40MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210632-003LEVOTHYROXINE SODIUM500MCG/5ML (100MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210632-001LEVOTHYROXINE SODIUM100MCG/5ML (20MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210632-002LEVOTHYROXINE SODIUM200MCG/5ML (40MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210632-003LEVOTHYROXINE SODIUM500MCG/5ML (100MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210632-001LEVOTHYROXINE SODIUM100MCG/5ML (20MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210632-002LEVOTHYROXINE SODIUM200MCG/5ML (40MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210632-003LEVOTHYROXINE SODIUM500MCG/5ML (100MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210632-001LEVOTHYROXINE SODIUM100MCG/5ML (20MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210632-002LEVOTHYROXINE SODIUM200MCG/5ML (40MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210632-003LEVOTHYROXINE SODIUM500MCG/5ML (100MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210632-001LEVOTHYROXINE SODIUM100MCG/5ML (20MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210632-002LEVOTHYROXINE SODIUM200MCG/5ML (40MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210632-003LEVOTHYROXINE SODIUM500MCG/5ML (100MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210632-001LEVOTHYROXINE SODIUM100MCG/5ML (20MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210632-002LEVOTHYROXINE SODIUM200MCG/5ML (40MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210632-003LEVOTHYROXINE SODIUM500MCG/5ML (100MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N210632-001LEVOTHYROXINE SODIUM100MCG/5ML (20MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-11d06236e962d9…
2024-10-29 15:01 UTC2024-10N210632-002LEVOTHYROXINE SODIUM200MCG/5ML (40MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-11d06236e962d9…
2024-10-29 15:01 UTC2024-10N210632-003LEVOTHYROXINE SODIUM500MCG/5ML (100MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210632-001LEVOTHYROXINE SODIUM100MCG/5ML (20MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210632-002LEVOTHYROXINE SODIUM200MCG/5ML (40MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210632-003LEVOTHYROXINE SODIUM500MCG/5ML (100MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210632-001LEVOTHYROXINE SODIUM100MCG/5ML (20MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210632-002LEVOTHYROXINE SODIUM200MCG/5ML (40MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210632-003LEVOTHYROXINE SODIUM500MCG/5ML (100MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N210632-001LEVOTHYROXINE SODIUM100MCG/5ML (20MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N210632-002LEVOTHYROXINE SODIUM200MCG/5ML (40MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N210632-003LEVOTHYROXINE SODIUM500MCG/5ML (100MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05N210632-001LEVOTHYROXINE SODIUM100MCG/5ML (20MCG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-04-118072bd15b7f6…

Observed Orange Book patent history#

Patent history page 1 of 9 · 342 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N210632-001103986692036-12-01Drug product2019-09-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210632-001111351902036-12-01Drug product2021-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210632-00197823762036-12-01Drug product2019-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210632-002103986692036-12-01Drug product2019-09-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210632-002111351902036-12-01Drug product2021-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210632-00297823762036-12-01Drug product2019-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210632-003103986692036-12-01Drug product2019-09-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210632-003111351902036-12-01Drug product2021-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210632-00397823762036-12-01Drug product2019-06-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210632-001103986692036-12-01Drug product2019-09-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210632-001111351902036-12-01Drug product2021-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210632-00197823762036-12-01Drug product2019-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210632-002103986692036-12-01Drug product2019-09-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210632-002111351902036-12-01Drug product2021-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210632-00297823762036-12-01Drug product2019-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210632-003103986692036-12-01Drug product2019-09-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210632-003111351902036-12-01Drug product2021-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210632-00397823762036-12-01Drug product2019-06-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N210632-001103986692036-12-01Drug product2019-09-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210632-001111351902036-12-01Drug product2021-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210632-00197823762036-12-01Drug product2019-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210632-002103986692036-12-01Drug product2019-09-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210632-002111351902036-12-01Drug product2021-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210632-00297823762036-12-01Drug product2019-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210632-003103986692036-12-01Drug product2019-09-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210632-003111351902036-12-01Drug product2021-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210632-00397823762036-12-01Drug product2019-06-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210632-001103986692036-12-01Drug product2019-09-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210632-001111351902036-12-01Drug product2021-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210632-00197823762036-12-01Drug product2019-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210632-002103986692036-12-01Drug product2019-09-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210632-002111351902036-12-01Drug product2021-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210632-00297823762036-12-01Drug product2019-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210632-003103986692036-12-01Drug product2019-09-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210632-003111351902036-12-01Drug product2021-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210632-00397823762036-12-01Drug product2019-06-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210632-001103986692036-12-01Drug product2019-09-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210632-001111351902036-12-01Drug product2021-10-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210632-00197823762036-12-01Drug product2019-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210632-002103986692036-12-01Drug product2019-09-13b8a1b40f171c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM100 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9J765S329GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2166148Internal RxNorm lookup
2166193Internal RxNorm lookup
2166196Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
08f4b1f8-6807-47e7-bef8-8d1972aa0557Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
97c252d3-9bb8-4530-bb44-9824dc7cf556Product name620250729
6c43b71c-35e6-4db3-ba24-c6ef42ff7003Product name320240207
890fd4bf-1a80-42b7-be1b-2d0259d5f0c8Product name520240207
c8ad26bf-af73-460b-b74e-1eff16cc4f9fProduct name520240207
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
01383843-4069-43cf-aa76-dc17a6f9f8c4Product name220230123
978cca7d-a938-4791-8322-da48d90a63efProduct name120230113
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
65f86ba3-8816-4e12-899b-18290c8de551Product name220210614
f16ab90f-08c2-40be-a543-66d9827cd1f3Product name120210601
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6a33ec05-2ae2-45e5-ab82-2d94b3303923Product name120190709
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
93355a10-1c44-4c92-a11d-7d995e0200d9Product name120190219
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-895-10Levothyroxine Sodium1 in 1 CARTONINJECTION, SOLUTION14
63323-895-10Levothyroxine Sodium5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-895-10ML - Milliliter63323-8954a507d7c-62ef-40e2-801c-3ddb8c39575912019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-895LEVOTHYROXINE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20250419_08f4b1f8-6807-47e7-bef8-8d1972aa0557.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine SodiumLEVOTHYROXINE SODIUMFresenius Kabi USA, LLC08f4b1f8-6807-47e7-bef8-8d1972aa05572025-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 210632
application number: NDA210632
ndc (package): 63323-895-10
ndc (product): 63323-895
ndc11 (package): 63323089510
Levothyroxine SodiumLEVOTHYROXINE SODIUMFresenius Kabi USA, LLC388a1f15-8c1c-46a5-997f-7f326f696b592020-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 210632
application number: NDA210632
Levothyroxine SodiumLEVOTHYROXINE SODIUMFresenius Kabi USA, LLC50b1c8a4-75b6-49c8-80fc-3841ee80b1832020-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 210632
application number: NDA210632

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2166193levothyroxine sodium 100 MCG in 5 mL InjectionPSN08f4b1f8-6807-47e7-bef8-8d1972aa05574
2166196levothyroxine sodium 200 MCG in 5 mL InjectionPSN08f4b1f8-6807-47e7-bef8-8d1972aa05574
2166148levothyroxine sodium 500 MCG in 5 mL InjectionPSN08f4b1f8-6807-47e7-bef8-8d1972aa05574
21661935 ML levothyroxine sodium 0.02 MG/ML InjectionSCD08f4b1f8-6807-47e7-bef8-8d1972aa05574
21661965 ML levothyroxine sodium 0.04 MG/ML InjectionSCD08f4b1f8-6807-47e7-bef8-8d1972aa05574
21661485 ML levothyroxine sodium 0.1 MG/ML InjectionSCD08f4b1f8-6807-47e7-bef8-8d1972aa05574
2166193levothyroxine sodium 100 MCG per 5 ML InjectionSY08f4b1f8-6807-47e7-bef8-8d1972aa05574
2166148levothyroxine sodium 100 MCG/ML in 5 ML InjectionSY08f4b1f8-6807-47e7-bef8-8d1972aa05574
2166193levothyroxine sodium 20 MCG/ML in 5 ML InjectionSY08f4b1f8-6807-47e7-bef8-8d1972aa05574
2166196levothyroxine sodium 200 MCG per 5 ML InjectionSY08f4b1f8-6807-47e7-bef8-8d1972aa05574
2166196levothyroxine sodium 40 MCG/ML in 5 ML InjectionSY08f4b1f8-6807-47e7-bef8-8d1972aa05574
2166148levothyroxine sodium 500 MCG per 5 ML InjectionSY08f4b1f8-6807-47e7-bef8-8d1972aa05574

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63323-895-10633230895101 VIAL, SINGLE-DOSE in 1 CARTON (63323-895-10) / 5 mL in 1 VIAL, SINGLE-DOSE2018-05-290000-00-00NoNoCurrent