Levothyroxine Sodium

Product NDC: 63323-885
Requested package NDC: 63323-885-10
11-digit product format: 633230885
Labeler code: 63323
Product ID: 63323-885_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: 20 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-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N210632-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11
N210632-002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11
N210632-003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N210632-001	10398669	2036-12-01	Drug product	2019-09-13
N210632-001	11135190	2036-12-01	Drug product	2021-10-07
N210632-001	12636270	2036-12-01	Drug product	2026-06-18
N210632-001	9782376	2036-12-01	Drug product	2019-06-11
N210632-002	10398669	2036-12-01	Drug product	2019-09-13
N210632-002	11135190	2036-12-01	Drug product	2021-10-07
N210632-002	12636270	2036-12-01	Drug product	2026-06-18
N210632-002	9782376	2036-12-01	Drug product	2019-06-11
N210632-003	10398669	2036-12-01	Drug product	2019-09-13
N210632-003	11135190	2036-12-01	Drug product	2021-10-07
N210632-003	12636270	2036-12-01	Drug product	2026-06-18
N210632-003	9782376	2036-12-01	Drug product	2019-06-11

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 342 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210632-001	10398669	2036-12-01	Drug product	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210632-001	11135190	2036-12-01	Drug product	2021-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210632-001	9782376	2036-12-01	Drug product	2019-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210632-002	10398669	2036-12-01	Drug product	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210632-002	11135190	2036-12-01	Drug product	2021-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210632-002	9782376	2036-12-01	Drug product	2019-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210632-003	10398669	2036-12-01	Drug product	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210632-003	11135190	2036-12-01	Drug product	2021-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210632-003	9782376	2036-12-01	Drug product	2019-06-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210632-001	10398669	2036-12-01	Drug product	2019-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210632-001	11135190	2036-12-01	Drug product	2021-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210632-001	9782376	2036-12-01	Drug product	2019-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210632-002	10398669	2036-12-01	Drug product	2019-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210632-002	11135190	2036-12-01	Drug product	2021-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210632-002	9782376	2036-12-01	Drug product	2019-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210632-003	10398669	2036-12-01	Drug product	2019-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210632-003	11135190	2036-12-01	Drug product	2021-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210632-003	9782376	2036-12-01	Drug product	2019-06-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210632-001	10398669	2036-12-01	Drug product	2019-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210632-001	11135190	2036-12-01	Drug product	2021-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210632-001	9782376	2036-12-01	Drug product	2019-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210632-002	10398669	2036-12-01	Drug product	2019-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210632-002	11135190	2036-12-01	Drug product	2021-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210632-002	9782376	2036-12-01	Drug product	2019-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210632-003	10398669	2036-12-01	Drug product	2019-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210632-003	11135190	2036-12-01	Drug product	2021-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210632-003	9782376	2036-12-01	Drug product	2019-06-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210632-001	10398669	2036-12-01	Drug product	2019-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210632-001	11135190	2036-12-01	Drug product	2021-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210632-001	9782376	2036-12-01	Drug product	2019-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210632-002	10398669	2036-12-01	Drug product	2019-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210632-002	11135190	2036-12-01	Drug product	2021-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210632-002	9782376	2036-12-01	Drug product	2019-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210632-003	10398669	2036-12-01	Drug product	2019-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210632-003	11135190	2036-12-01	Drug product	2021-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210632-003	9782376	2036-12-01	Drug product	2019-06-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210632-001	10398669	2036-12-01	Drug product	2019-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210632-001	11135190	2036-12-01	Drug product	2021-10-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210632-001	9782376	2036-12-01	Drug product	2019-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210632-002	10398669	2036-12-01	Drug product	2019-09-13	`b8a1b40f171c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVOTHYROXINE SODIUM	20 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9J765S329G	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
08f4b1f8-6807-47e7-bef8-8d1972aa0557	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
97c252d3-9bb8-4530-bb44-9824dc7cf556	Product name	6	20250729
6c43b71c-35e6-4db3-ba24-c6ef42ff7003	Product name	3	20240207
890fd4bf-1a80-42b7-be1b-2d0259d5f0c8	Product name	5	20240207
c8ad26bf-af73-460b-b74e-1eff16cc4f9f	Product name	5	20240207
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
01383843-4069-43cf-aa76-dc17a6f9f8c4	Product name	2	20230123
978cca7d-a938-4791-8322-da48d90a63ef	Product name	1	20230113
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
65f86ba3-8816-4e12-899b-18290c8de551	Product name	2	20210614
f16ab90f-08c2-40be-a543-66d9827cd1f3	Product name	1	20210601
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6a33ec05-2ae2-45e5-ab82-2d94b3303923	Product name	1	20190709
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
93355a10-1c44-4c92-a11d-7d995e0200d9	Product name	1	20190219
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63323-885-10	Levothyroxine Sodium	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	5	4
63323-885-10	Levothyroxine Sodium	1 in 1 CARTON	INJECTION, SOLUTION	1	4
63323-885-12	Levothyroxine Sodium	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	5	1
63323-885-12	Levothyroxine Sodium	1 in 1 CARTON	INJECTION, SOLUTION	1	1
63323-885-14	Levothyroxine Sodium	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	5	1
63323-885-14	Levothyroxine Sodium	1 in 1 CARTON	INJECTION, SOLUTION	1	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-885-10	ML - Milliliter	63323-885	d4060697-dbe3-41da-84bb-1a1e213d57a1	1	2019-06-19
63323-885-12	ML - Milliliter	63323-885	fd862941-90d5-4e9d-973b-75c6f82ef0a4	1	2021-03-02
63323-885-14	ML - Milliliter	63323-885	1aa98018-ab28-492b-8922-3ae6eaf6a42e	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-885	LEVOTHYROXINE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4	Current NDC, Legacy NDC, 2 package rows	20250419_08f4b1f8-6807-47e7-bef8-8d1972aa0557.zip
63323-885	LEVOTHYROXINE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1	Current NDC, Legacy NDC, 2 package rows	20201210_50b1c8a4-75b6-49c8-80fc-3841ee80b183.zip
63323-885	LEVOTHYROXINE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1	Current NDC, Legacy NDC, 2 package rows	20201210_388a1f15-8c1c-46a5-997f-7f326f696b59.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Fresenius Kabi USA, LLC	08f4b1f8-6807-47e7-bef8-8d1972aa0557	2025-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 210632 application number: NDA210632 ndc (package): 63323-885-10 ndc (product): 63323-885 ndc11 (package): 63323088510
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Fresenius Kabi USA, LLC	388a1f15-8c1c-46a5-997f-7f326f696b59	2020-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 210632 application number: NDA210632 ndc (product): 63323-885
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Fresenius Kabi USA, LLC	50b1c8a4-75b6-49c8-80fc-3841ee80b183	2020-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 210632 application number: NDA210632 ndc (product): 63323-885

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9J765S329G	LEVOTHYROXINE SODIUM	6106-07-6	LEVOTHYROXINE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2166193	levothyroxine sodium 100 MCG in 5 mL Injection	PSN	08f4b1f8-6807-47e7-bef8-8d1972aa0557	4
2166196	levothyroxine sodium 200 MCG in 5 mL Injection	PSN	08f4b1f8-6807-47e7-bef8-8d1972aa0557	4
2166148	levothyroxine sodium 500 MCG in 5 mL Injection	PSN	08f4b1f8-6807-47e7-bef8-8d1972aa0557	4
2166193	5 ML levothyroxine sodium 0.02 MG/ML Injection	SCD	08f4b1f8-6807-47e7-bef8-8d1972aa0557	4
2166196	5 ML levothyroxine sodium 0.04 MG/ML Injection	SCD	08f4b1f8-6807-47e7-bef8-8d1972aa0557	4
2166148	5 ML levothyroxine sodium 0.1 MG/ML Injection	SCD	08f4b1f8-6807-47e7-bef8-8d1972aa0557	4
2166193	levothyroxine sodium 100 MCG per 5 ML Injection	SY	08f4b1f8-6807-47e7-bef8-8d1972aa0557	4
2166148	levothyroxine sodium 100 MCG/ML in 5 ML Injection	SY	08f4b1f8-6807-47e7-bef8-8d1972aa0557	4
2166193	levothyroxine sodium 20 MCG/ML in 5 ML Injection	SY	08f4b1f8-6807-47e7-bef8-8d1972aa0557	4
2166196	levothyroxine sodium 200 MCG per 5 ML Injection	SY	08f4b1f8-6807-47e7-bef8-8d1972aa0557	4
2166196	levothyroxine sodium 40 MCG/ML in 5 ML Injection	SY	08f4b1f8-6807-47e7-bef8-8d1972aa0557	4
2166148	levothyroxine sodium 500 MCG per 5 ML Injection	SY	08f4b1f8-6807-47e7-bef8-8d1972aa0557	4
2166193	levothyroxine sodium 100 MCG in 5 mL Injection	PSN	388a1f15-8c1c-46a5-997f-7f326f696b59	1
2166193	levothyroxine sodium 100 MCG in 5 mL Injection	PSN	50b1c8a4-75b6-49c8-80fc-3841ee80b183	1
2166193	5 ML levothyroxine sodium 0.02 MG/ML Injection	SCD	388a1f15-8c1c-46a5-997f-7f326f696b59	1
2166193	5 ML levothyroxine sodium 0.02 MG/ML Injection	SCD	50b1c8a4-75b6-49c8-80fc-3841ee80b183	1
2166193	levothyroxine sodium 100 MCG per 5 ML Injection	SY	388a1f15-8c1c-46a5-997f-7f326f696b59	1
2166193	levothyroxine sodium 100 MCG per 5 ML Injection	SY	50b1c8a4-75b6-49c8-80fc-3841ee80b183	1
2166193	levothyroxine sodium 20 MCG/ML in 5 ML Injection	SY	388a1f15-8c1c-46a5-997f-7f326f696b59	1
2166193	levothyroxine sodium 20 MCG/ML in 5 ML Injection	SY	50b1c8a4-75b6-49c8-80fc-3841ee80b183	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-885-10	63323088510	1 VIAL, SINGLE-DOSE in 1 CARTON (63323-885-10) / 5 mL in 1 VIAL, SINGLE-DOSE	2018-05-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levothyroxine Sodium	Fresenius Kabi USA, LLC	2025-03-17	HUMAN PRESCRIPTION DRUG LABEL	4
Levothyroxine Sodium	Fresenius Kabi USA, LLC	2020-12-04	HUMAN PRESCRIPTION DRUG LABEL	1
Levothyroxine Sodium	Fresenius Kabi USA, LLC	2020-12-04	HUMAN PRESCRIPTION DRUG LABEL	1