Levothyroxine Sodium

Product NDC
70934-836
Requested package NDC
70934-836-90
11-digit product format
709340836
Labeler code
70934
Product ID
70934-836_bd58da93-25b5-3da5-e053-2a95a90a037b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA076187
Marketing category
ANDA
Marketing start
2021-03-11
Marketing end
0000-00-00
Substance
LEVOTHYROXINE SODIUM
Active strength
50 ug/1
Pharmacologic classes
l-Thyroxine [EPC],Thyroxine [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70934-83670934-836-90DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 12 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076187-001LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05
A076187-002LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05
A076187-003LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05
A076187-004LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05
A076187-005LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05
A076187-006LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05
A076187-007LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05
A076187-008LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05
A076187-009LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05
A076187-010LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05
A076187-011LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB4RS2002-06-05
A076187-012LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42006-12-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 48 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 13 · 516 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076187-001LEVOTHYROXINE SODIUM0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-0584e616aacf4f…
2026-09-14 22:38:342026-08A076187-002LEVOTHYROXINE SODIUM0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-0584e616aacf4f…
2026-09-14 22:38:342026-08A076187-003LEVOTHYROXINE SODIUM0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-0584e616aacf4f…
2026-09-14 22:38:342026-08A076187-004LEVOTHYROXINE SODIUM0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-0584e616aacf4f…
2026-09-14 22:38:342026-08A076187-005LEVOTHYROXINE SODIUM0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-0584e616aacf4f…
2026-09-14 22:38:342026-08A076187-006LEVOTHYROXINE SODIUM0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-0584e616aacf4f…
2026-09-14 22:38:342026-08A076187-007LEVOTHYROXINE SODIUM0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-0584e616aacf4f…
2026-09-14 22:38:342026-08A076187-008LEVOTHYROXINE SODIUM0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-0584e616aacf4f…
2026-09-14 22:38:342026-08A076187-009LEVOTHYROXINE SODIUM0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-0584e616aacf4f…
2026-09-14 22:38:342026-08A076187-010LEVOTHYROXINE SODIUM0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-0584e616aacf4f…
2026-09-14 22:38:342026-08A076187-011LEVOTHYROXINE SODIUM0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB4RS2002-06-0584e616aacf4f…
2026-09-14 22:38:342026-08A076187-012LEVOTHYROXINE SODIUM0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42006-12-1384e616aacf4f…
2026-08-18 06:07:402026-07A076187-001LEVOTHYROXINE SODIUM0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05caaa826d4ba7…
2026-08-18 06:07:402026-07A076187-002LEVOTHYROXINE SODIUM0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05caaa826d4ba7…
2026-08-18 06:07:402026-07A076187-003LEVOTHYROXINE SODIUM0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05caaa826d4ba7…
2026-08-18 06:07:402026-07A076187-004LEVOTHYROXINE SODIUM0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05caaa826d4ba7…
2026-08-18 06:07:402026-07A076187-005LEVOTHYROXINE SODIUM0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05caaa826d4ba7…
2026-08-18 06:07:402026-07A076187-006LEVOTHYROXINE SODIUM0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05caaa826d4ba7…
2026-08-18 06:07:402026-07A076187-007LEVOTHYROXINE SODIUM0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05caaa826d4ba7…
2026-08-18 06:07:402026-07A076187-008LEVOTHYROXINE SODIUM0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05caaa826d4ba7…
2026-08-18 06:07:402026-07A076187-009LEVOTHYROXINE SODIUM0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05caaa826d4ba7…
2026-08-18 06:07:402026-07A076187-010LEVOTHYROXINE SODIUM0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05caaa826d4ba7…
2026-08-18 06:07:402026-07A076187-011LEVOTHYROXINE SODIUM0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB4RS2002-06-05caaa826d4ba7…
2026-08-18 06:07:402026-07A076187-012LEVOTHYROXINE SODIUM0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42006-12-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076187-001LEVOTHYROXINE SODIUM0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076187-002LEVOTHYROXINE SODIUM0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076187-003LEVOTHYROXINE SODIUM0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076187-004LEVOTHYROXINE SODIUM0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076187-005LEVOTHYROXINE SODIUM0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076187-006LEVOTHYROXINE SODIUM0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076187-007LEVOTHYROXINE SODIUM0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076187-008LEVOTHYROXINE SODIUM0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076187-009LEVOTHYROXINE SODIUM0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076187-010LEVOTHYROXINE SODIUM0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076187-011LEVOTHYROXINE SODIUM0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB4RS2002-06-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076187-012LEVOTHYROXINE SODIUM0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42006-12-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076187-001LEVOTHYROXINE SODIUM0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076187-002LEVOTHYROXINE SODIUM0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076187-003LEVOTHYROXINE SODIUM0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076187-004LEVOTHYROXINE SODIUM0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42002-06-0531067a03dcf5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 52 · 2,064 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A076187-001AB1184e616aacf4f…
2026-09-14 22:38:342026-08A076187-001AB2284e616aacf4f…
2026-09-14 22:38:342026-08A076187-001AB3384e616aacf4f…
2026-09-14 22:38:342026-08A076187-001AB4484e616aacf4f…
2026-09-14 22:38:342026-08A076187-002AB1184e616aacf4f…
2026-09-14 22:38:342026-08A076187-002AB2284e616aacf4f…
2026-09-14 22:38:342026-08A076187-002AB3384e616aacf4f…
2026-09-14 22:38:342026-08A076187-002AB4484e616aacf4f…
2026-09-14 22:38:342026-08A076187-003AB1184e616aacf4f…
2026-09-14 22:38:342026-08A076187-003AB2284e616aacf4f…
2026-09-14 22:38:342026-08A076187-003AB3384e616aacf4f…
2026-09-14 22:38:342026-08A076187-003AB4484e616aacf4f…
2026-09-14 22:38:342026-08A076187-004AB1184e616aacf4f…
2026-09-14 22:38:342026-08A076187-004AB2284e616aacf4f…
2026-09-14 22:38:342026-08A076187-004AB3384e616aacf4f…
2026-09-14 22:38:342026-08A076187-004AB4484e616aacf4f…
2026-09-14 22:38:342026-08A076187-005AB1184e616aacf4f…
2026-09-14 22:38:342026-08A076187-005AB2284e616aacf4f…
2026-09-14 22:38:342026-08A076187-005AB3384e616aacf4f…
2026-09-14 22:38:342026-08A076187-005AB4484e616aacf4f…
2026-09-14 22:38:342026-08A076187-006AB1184e616aacf4f…
2026-09-14 22:38:342026-08A076187-006AB2284e616aacf4f…
2026-09-14 22:38:342026-08A076187-006AB3384e616aacf4f…
2026-09-14 22:38:342026-08A076187-006AB4484e616aacf4f…
2026-09-14 22:38:342026-08A076187-007AB1184e616aacf4f…
2026-09-14 22:38:342026-08A076187-007AB2284e616aacf4f…
2026-09-14 22:38:342026-08A076187-007AB3384e616aacf4f…
2026-09-14 22:38:342026-08A076187-007AB4484e616aacf4f…
2026-09-14 22:38:342026-08A076187-008AB1184e616aacf4f…
2026-09-14 22:38:342026-08A076187-008AB2284e616aacf4f…
2026-09-14 22:38:342026-08A076187-008AB3384e616aacf4f…
2026-09-14 22:38:342026-08A076187-008AB4484e616aacf4f…
2026-09-14 22:38:342026-08A076187-009AB1184e616aacf4f…
2026-09-14 22:38:342026-08A076187-009AB2284e616aacf4f…
2026-09-14 22:38:342026-08A076187-009AB3384e616aacf4f…
2026-09-14 22:38:342026-08A076187-009AB4484e616aacf4f…
2026-09-14 22:38:342026-08A076187-010AB1184e616aacf4f…
2026-09-14 22:38:342026-08A076187-010AB2284e616aacf4f…
2026-09-14 22:38:342026-08A076187-010AB3384e616aacf4f…
2026-09-14 22:38:342026-08A076187-010AB4484e616aacf4f…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-836-30EA - Each70934-836dd13a51f-a6bb-45bb-9038-618b214bb51412022-12-07
70934-836-90EA - Each70934-8368a347b69-9e6f-45b2-b4da-f67bcc79747412022-12-07

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine SodiumLEVOTHYROXINE SODIUMCardinal Health 107, LLC66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf2026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076187
application number: ANDA076187
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCdb10e666-6204-56cc-e053-2995a90a9e082026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076187
application number: ANDA076187
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCfa15ac73-f4f6-7a6b-e053-6294a90a4f4e2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076187
application number: ANDA076187
Levothyroxine SodiumLEVOTHYROXINE SODIUMMylan Institutional Inc.cd69c192-cd3f-47e6-b0a6-c536ffed5c4b2025-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076187
application number: ANDA076187
Levothyroxine SodiumLEVOTHYROXINE SODIUMMylan Institutional Inc.5723c7a7-2a1d-4ab6-bf39-b2165ae781a62025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076187
application number: ANDA076187
Levothyroxine SodiumLEVOTHYROXINE SODIUMMylan Pharmaceuticals Inc.e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc2024-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076187
application number: ANDA076187

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-836-907093408369090 TABLET in 1 BOTTLE, PLASTIC (70934-836-90) 90 tablet2021-03-170000-00-00NoNoCurrent