Home NDC 24201-002 Levothyroxine Sodium
Product NDC 24201-002
11-digit product format 242010002
Labeler code 24201
Product ID 24201-002_563fecaf-128d-4f6b-81c8-715b4d90a261
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LEVOTHYROXINE SODIUM
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application NDA214253
Marketing category NDA
Marketing start 2022-11-15
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214253-001 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214253-001 11154498 2036-07-20 Drug product 2021-10-27
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.
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 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214253-001 LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2021-05-17 a50c72e98297…
Observed Orange Book patent history# 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 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214253-001 11154498 2036-07-20 Drug product 2021-10-27 a50c72e98297…
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 100 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2621123 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 24201-002-01 Levothyroxine Sodium 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2 4 24201-002-01 Levothyroxine Sodium 1 in 1 CARTON INJECTION, SOLUTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24201-002 LEVOTHYROXINE SODIUM INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 4 Current NDC, Legacy NDC, 2 package rows 20250522_6279390b-ee61-4ef9-ac15-25537ca783c1.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 · 1 matching rows.
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 24201-002-01 24201000201 1 VIAL, SINGLE-DOSE in 1 CARTON (24201-002-01) / 2 mL in 1 VIAL, SINGLE-DOSE 2022-11-15 0000-00-00 No No Current