Home NDC 63323-890-10 Levothyroxine Sodium
Product NDC 63323-890
Requested package NDC 63323-890-10
11-digit product format 633230890
Labeler code 63323
Product ID 63323-890_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 40 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 TE codes 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 Use code 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 Product TE source text 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 Use code 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 40 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63323-890-10 Levothyroxine Sodium 1 in 1 CARTON INJECTION, SOLUTION 1 4 63323-890-10 Levothyroxine Sodium 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-890 LEVOTHYROXINE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20250419_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 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): 63323-890-10 ndc (product): 63323-890 ndc11 (package): 63323089010 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 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63323-890-10 63323089010 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-890-10) / 5 mL in 1 VIAL, SINGLE-DOSE 2018-05-29 0000-00-00 No No Current