Home NDC 70511-112 Levothyroxine Sodium
Product NDC 70511-112
11-digit product format 705110112
Labeler code 70511
Product ID 70511-112_9efa2867-7721-478a-a1c3-e34eeb3a1937
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LEVOTHYROXINE SODIUM ANHYDROUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler MAIA Pharmaceuticals, Inc.
Application ANDA208749
Marketing category ANDA
Marketing start 2018-12-27
Substance LEVOTHYROXINE SODIUM ANHYDROUS
Active strength 200 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 A208749-001 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 A208749-002 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 A208749-003 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21
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.
Product history page 1 of 4 · 126 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 A208749-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208749-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208749-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208749-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208749-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208749-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208749-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208749-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208749-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208749-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208749-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208749-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208749-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208749-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208749-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208749-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208749-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208749-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208749-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208749-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208749-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208749-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208749-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208749-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208749-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208749-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208749-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208749-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208749-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208749-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208749-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208749-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208749-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208749-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208749-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208749-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208749-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208749-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208749-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208749-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 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 200 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 966219 Internal RxNorm lookup 1115267 Internal RxNorm lookup 1115269 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 70511-112-10 Levothyroxine Sodium 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 4 70511-112-10 Levothyroxine Sodium 5 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70511-112 LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MAIA PHARMACEUTICALS, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20190131_4e9adc35-3aba-4a0d-9c4e-7e7ee2ffdabd.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 · 2 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 70511-112-10 70511011210 1 VIAL, SINGLE-USE in 1 CARTON (70511-112-10) / 5 mL in 1 VIAL, SINGLE-USE 2018-12-27 0000-00-00 No No Current