Home NDC 63323-649 Levothyroxine Sodium
Product NDC 63323-649
11-digit product format 633230649
Labeler code 63323
Product ID 63323-649_1da8e5bc-aeb7-4168-a8c3-e1d9a9d167ea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LEVOTHYROXINE SODIUM ANHYDROUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application NDA202231
Marketing category NDA
Marketing start 2011-06-24
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 N202231-001 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 N202231-002 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 N202231-003 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 9 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N202231-001 9168238 2032-08-29 Drug product 2015-10-28 N202231-001 9168239 2032-08-29 Drug product 2015-10-28 N202231-001 9006289 2032-10-03 Drug product 2015-04-14 N202231-002 9168238 2032-08-29 Drug product 2015-10-28 N202231-002 9168239 2032-08-29 Drug product 2015-10-28 N202231-002 9006289 2032-10-03 Drug product 2015-04-14 N202231-003 9168238 2032-08-29 Drug product 2015-10-28 N202231-003 9168239 2032-08-29 Drug product 2015-10-28 N202231-003 9006289 2032-10-03 Drug product 2015-04-14
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 N202231-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202231-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202231-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N202231-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202231-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202231-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202231-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202231-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202231-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202231-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202231-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202231-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202231-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202231-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202231-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202231-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202231-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202231-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202231-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202231-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202231-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202231-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202231-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202231-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202231-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202231-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202231-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202231-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202231-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202231-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202231-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202231-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202231-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202231-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202231-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202231-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202231-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202231-002 LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202231-003 LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202231-001 LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2011-06-24 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Observed Orange Book patent history# Patent history page 1 of 10 · 378 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N202231-001 9168238 2032-08-29 Drug product 2015-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202231-001 9168239 2032-08-29 Drug product 2015-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202231-001 9006289 2032-10-03 Drug product 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202231-002 9168238 2032-08-29 Drug product 2015-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202231-002 9168239 2032-08-29 Drug product 2015-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202231-002 9006289 2032-10-03 Drug product 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202231-003 9168238 2032-08-29 Drug product 2015-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202231-003 9168239 2032-08-29 Drug product 2015-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202231-003 9006289 2032-10-03 Drug product 2015-04-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N202231-001 9168238 2032-08-29 Drug product 2015-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202231-001 9168239 2032-08-29 Drug product 2015-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202231-001 9006289 2032-10-03 Drug product 2015-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202231-002 9168238 2032-08-29 Drug product 2015-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202231-002 9168239 2032-08-29 Drug product 2015-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202231-002 9006289 2032-10-03 Drug product 2015-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202231-003 9168238 2032-08-29 Drug product 2015-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202231-003 9168239 2032-08-29 Drug product 2015-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202231-003 9006289 2032-10-03 Drug product 2015-04-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202231-001 9168238 2032-08-29 Drug product 2015-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202231-001 9168239 2032-08-29 Drug product 2015-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202231-001 9006289 2032-10-03 Drug product 2015-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202231-002 9168238 2032-08-29 Drug product 2015-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202231-002 9168239 2032-08-29 Drug product 2015-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202231-002 9006289 2032-10-03 Drug product 2015-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202231-003 9168238 2032-08-29 Drug product 2015-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202231-003 9168239 2032-08-29 Drug product 2015-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202231-003 9006289 2032-10-03 Drug product 2015-04-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202231-001 9168238 2032-08-29 Drug product 2015-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202231-001 9168239 2032-08-29 Drug product 2015-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202231-001 9006289 2032-10-03 Drug product 2015-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202231-002 9168238 2032-08-29 Drug product 2015-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202231-002 9168239 2032-08-29 Drug product 2015-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202231-002 9006289 2032-10-03 Drug product 2015-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202231-003 9168238 2032-08-29 Drug product 2015-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202231-003 9168239 2032-08-29 Drug product 2015-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202231-003 9006289 2032-10-03 Drug product 2015-04-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202231-001 9168238 2032-08-29 Drug product 2015-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202231-001 9168239 2032-08-29 Drug product 2015-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202231-001 9006289 2032-10-03 Drug product 2015-04-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202231-002 9168238 2032-08-29 Drug product 2015-10-28 fd3edfee7708…
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 · 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 63323-649-07 Levothyroxine Sodium 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 7 63323-649-07 Levothyroxine Sodium 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 5 7 63323-649-16 Levothyroxine Sodium 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 5 63323-649-16 Levothyroxine Sodium 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 5 5 63323-649-94 Levothyroxine Sodium 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 5 63323-649-94 Levothyroxine Sodium 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 5 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEVOTHYROXINE SODIUM ANHYDROUS ACTIVE INGREDIENT 054I36CPMN LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 3 LEVOTHYROXINE ACTIVE MOIETY Q51BO43MG4 LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 3 MANNITOL INACTIVE INGREDIENT 3OWL53L36A LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 3 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 3 SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE INACTIVE INGREDIENT 70WT22SF4B LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 3 LEVOTHYROXINE SODIUM ANHYDROUS ACTIVE INGREDIENT 054I36CPMN LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 LEVOTHYROXINE ACTIVE MOIETY Q51BO43MG4 LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 MANNITOL INACTIVE INGREDIENT 3OWL53L36A LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE INACTIVE INGREDIENT 70WT22SF4B LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 LEVOTHYROXINE SODIUM ANHYDROUS ACTIVE INGREDIENT 054I36CPMN LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 LEVOTHYROXINE ACTIVE MOIETY Q51BO43MG4 LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE INACTIVE INGREDIENT 70WT22SF4B LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-649 LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 7 Current NDC, Legacy NDC, 2 package rows 20250426_ce990712-49c1-4f66-9ee4-c770e8ec394c.zip 63323-649 LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20241019_152d071f-d4aa-46d2-b397-61c1cabdd86d.zip 63323-649 LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20241019_f88f44d8-2f18-4155-9d78-6323d19fbafe.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Levothyroxine Sodium LEVOTHYROXINE SODIUM ANHYDROUS ENDO USA, Inc. 9d815416-11c9-470e-a82f-89b0bf232e12 2025-04-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 202231 application number: NDA202231 Levothyroxine Sodium LEVOTHYROXINE SODIUM ANHYDROUS Fresenius Kabi USA, LLC ce990712-49c1-4f66-9ee4-c770e8ec394c 2025-04-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 202231 application number: NDA202231 ndc (product): 63323-649 Levothyroxine Sodium LEVOTHYROXINE SODIUM ANHYDROUS Fresenius Kabi USA, LLC 152d071f-d4aa-46d2-b397-61c1cabdd86d 2024-10-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 202231 application number: NDA202231 ndc (product): 63323-649 Levothyroxine Sodium LEVOTHYROXINE SODIUM ANHYDROUS Fresenius Kabi USA, LLC f88f44d8-2f18-4155-9d78-6323d19fbafe 2024-10-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 202231 application number: NDA202231 ndc (product): 63323-649
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 63323-649-07 63323064907 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-649-07) / 5 mL in 1 VIAL, SINGLE-DOSE 2011-06-24 0000-00-00 No No Current 63323-649-16 63323064916 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-649-16) / 5 mL in 1 VIAL, SINGLE-DOSE 2011-06-24 0000-00-00 No No Current 63323-649-94 63323064994 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-649-94) / 5 mL in 1 VIAL, SINGLE-DOSE 2011-06-24 0000-00-00 No No Current