Home NDC 66794-200 Levothyroxine Sodium
Product NDC 66794-200
11-digit product format 667940200
Labeler code 66794
Product ID 66794-200_3f9e1bbc-d3e2-c795-e063-6394a90aecdf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levothyroxine Sodium
Dosage form INJECTION
Route INTRAVENOUS
Labeler Piramal Critical Care, Inc.
Application ANDA206163
Marketing category ANDA
Marketing start 2022-10-01
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206163-001 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS 2016-06-29 A206163-002 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS 2016-06-29
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 3 · 84 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 2026-08-18 06:07:40 2026-07 A206163-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS 2016-06-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206163-002 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS 2016-06-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206163-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206163-002 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206163-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206163-002 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206163-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206163-002 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206163-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206163-002 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206163-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206163-002 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206163-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206163-002 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206163-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206163-002 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206163-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206163-002 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206163-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206163-002 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206163-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206163-002 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206163-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206163-002 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206163-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206163-002 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206163-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206163-002 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206163-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206163-002 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206163-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206163-002 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206163-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206163-002 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206163-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206163-002 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206163-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206163-002 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206163-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206163-002 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2016-06-29 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 966219 Internal RxNorm lookup 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 66794-200-02 Levothyroxine Sodium 5 mL in 1 VIAL, SINGLE-USE INJECTION 5 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66794-200 LEVOTHYROXINE SODIUM INJECTION [PIRAMAL CRITICAL CARE, INC.] 7 Current NDC, Legacy NDC, 1 package rows 20241228_76139990-1355-cfb6-e053-2991aa0ace5b.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 Units Marketing start Marketing end Sample Exclude flag Status 66794-200-02 66794020002 5 mL in 1 VIAL, SINGLE-USE (66794-200-02) 5 ml 2022-10-01 0000-00-00 No No Current