Home NDC 72266-261 Levothyroxine Sodium
Product NDC 72266-261
11-digit product format 722660261
Labeler code 72266
Product ID 72266-261_33611328-03f9-d3f1-e063-6394a90ad483
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LEVOTHYROXINE SODIUM ANHYDROUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Fosun Pharma USA Inc.
Application ANDA216729
Marketing category ANDA
Marketing start 2025-09-18
Substance LEVOTHYROXINE SODIUM ANHYDROUS
Active strength 100 ug/5mL
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 42 .
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 A216729-001 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2025-03-05 A216729-002 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP 2025-03-05 A216729-003 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2025-03-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 2026-08-18 06:07:40 2026-07 A216729-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2025-03-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216729-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP 2025-03-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216729-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2025-03-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216729-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2025-03-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216729-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP 2025-03-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216729-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2025-03-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216729-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2025-03-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216729-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP 2025-03-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216729-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2025-03-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216729-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2025-03-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216729-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP 2025-03-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216729-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2025-03-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216729-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2025-03-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216729-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP 2025-03-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216729-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2025-03-05 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216729-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2025-03-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216729-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP 2025-03-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216729-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2025-03-05 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Levothyroxine Sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVOTHYROXINE SODIUM ANHYDROUS 100 ug/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 054I36CPMN Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1115267 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 72266-261-01 Levothyroxine Sodium 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 1 72266-261-01 Levothyroxine Sodium 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 5 1
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72266-261-01 72266026101 1 VIAL, SINGLE-DOSE in 1 CARTON (72266-261-01) / 5 mL in 1 VIAL, SINGLE-DOSE 2025-09-18 No No Current