FDA.reportPublic FDA data

National Council for Prescription Drug Programs indexing - billing unit

Manufacturer
National Council for Prescription Drug Programs
Effective date
2012-07-24
Label type
Indexing - Billing Unit
Version
1
Source
full-release
Hydrated at
2026-06-05 01:24:30

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5191-92EA - Each0781-519129e9cca7-b64e-4e20-9078-e9798c91c89a12012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0781-51910781-5191-92

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
N021342-001LEVO-TLEVOTHYROXINE SODIUM0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01
N021342-002LEVO-TLEVOTHYROXINE SODIUM0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01
N021342-003LEVO-TLEVOTHYROXINE SODIUM0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01
N021342-004LEVO-TLEVOTHYROXINE SODIUM0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01
N021342-005LEVO-TLEVOTHYROXINE SODIUM0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01
N021342-006LEVO-TLEVOTHYROXINE SODIUM0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01
N021342-007LEVO-TLEVOTHYROXINE SODIUM0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01
N021342-008LEVO-TLEVOTHYROXINE SODIUM0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01
N021342-009LEVO-TLEVOTHYROXINE SODIUM0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01
N021342-010LEVO-TLEVOTHYROXINE SODIUM0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01
N021342-011LEVO-TLEVOTHYROXINE SODIUM0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01
N021342-012LEVO-TLEVOTHYROXINE SODIUM0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32003-12-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 36 matching rows.

Application-product, TE code table
Application-productTE code
N021342-001AB1
N021342-001AB2
N021342-001AB3
N021342-002AB1
N021342-002AB2
N021342-002AB3
N021342-003AB1
N021342-003AB2
N021342-003AB3
N021342-004AB1
N021342-004AB2
N021342-004AB3
N021342-005AB1
N021342-005AB2
N021342-005AB3
N021342-006AB1
N021342-006AB2
N021342-006AB3
N021342-007AB1
N021342-007AB2
N021342-007AB3
N021342-008AB1
N021342-008AB2
N021342-008AB3
N021342-009AB1
N021342-009AB2
N021342-009AB3
N021342-010AB1
N021342-010AB2
N021342-010AB3
N021342-011AB1
N021342-011AB2
N021342-011AB3
N021342-012AB1
N021342-012AB2
N021342-012AB3

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 22:38:342026-08N021342-001LEVO-T0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0184e616aacf4f…
2026-09-14 22:38:342026-08N021342-002LEVO-T0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0184e616aacf4f…
2026-09-14 22:38:342026-08N021342-003LEVO-T0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0184e616aacf4f…
2026-09-14 22:38:342026-08N021342-004LEVO-T0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0184e616aacf4f…
2026-09-14 22:38:342026-08N021342-005LEVO-T0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0184e616aacf4f…
2026-09-14 22:38:342026-08N021342-006LEVO-T0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0184e616aacf4f…
2026-09-14 22:38:342026-08N021342-007LEVO-T0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0184e616aacf4f…
2026-09-14 22:38:342026-08N021342-008LEVO-T0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0184e616aacf4f…
2026-09-14 22:38:342026-08N021342-009LEVO-T0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0184e616aacf4f…
2026-09-14 22:38:342026-08N021342-010LEVO-T0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0184e616aacf4f…
2026-09-14 22:38:342026-08N021342-011LEVO-T0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0184e616aacf4f…
2026-09-14 22:38:342026-08N021342-012LEVO-T0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32003-12-0884e616aacf4f…
2026-08-18 06:07:402026-07N021342-001LEVO-T0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-002LEVO-T0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-003LEVO-T0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-004LEVO-T0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-005LEVO-T0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-006LEVO-T0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-007LEVO-T0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-008LEVO-T0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-009LEVO-T0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-010LEVO-T0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-011LEVO-T0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-012LEVO-T0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32003-12-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021342-001LEVO-T0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021342-002LEVO-T0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021342-003LEVO-T0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021342-004LEVO-T0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021342-005LEVO-T0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021342-006LEVO-T0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021342-007LEVO-T0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021342-008LEVO-T0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021342-009LEVO-T0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021342-010LEVO-T0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021342-011LEVO-T0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021342-012LEVO-T0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32003-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021342-001LEVO-T0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021342-002LEVO-T0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021342-003LEVO-T0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021342-004LEVO-T0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0131067a03dcf5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 39 · 1,548 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N021342-001AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021342-001AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021342-001AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021342-002AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021342-002AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021342-002AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021342-003AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021342-003AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021342-003AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021342-004AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021342-004AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021342-004AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021342-005AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021342-005AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021342-005AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021342-006AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021342-006AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021342-006AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021342-007AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021342-007AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021342-007AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021342-008AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021342-008AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021342-008AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021342-009AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021342-009AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021342-009AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021342-010AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021342-010AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021342-010AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021342-011AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021342-011AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021342-011AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021342-012AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021342-012AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021342-012AB3384e616aacf4f…
2026-08-18 06:07:402026-07N021342-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-001AB22caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-001AB33caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-002AB11caaa826d4ba7…

Observed Orange Book patent history#

Patent history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021342-00163991012020-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021342-00263991012020-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021342-00363991012020-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021342-00463991012020-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021342-00563991012020-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021342-00663991012020-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021342-00763991012020-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021342-00863991012020-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021342-00963991012020-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021342-01063991012020-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021342-01163991012020-03-3074a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021342-00163991012020-03-308869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021342-00263991012020-03-308869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021342-00363991012020-03-308869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021342-00463991012020-03-308869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021342-00563991012020-03-308869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021342-00663991012020-03-308869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021342-00763991012020-03-308869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021342-00863991012020-03-308869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021342-00963991012020-03-308869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021342-01063991012020-03-308869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021342-01163991012020-03-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021342-00163991012020-03-30c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021342-00263991012020-03-30c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021342-00363991012020-03-30c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021342-00463991012020-03-30c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021342-00563991012020-03-30c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021342-00663991012020-03-30c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021342-00763991012020-03-30c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021342-00863991012020-03-30c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021342-00963991012020-03-30c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021342-01063991012020-03-30c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021342-01163991012020-03-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021342-00163991012020-03-303f01610625f2…
2019-12-14 00:12 UTC2019-12N021342-00263991012020-03-303f01610625f2…
2019-12-14 00:12 UTC2019-12N021342-00363991012020-03-303f01610625f2…
2019-12-14 00:12 UTC2019-12N021342-00463991012020-03-303f01610625f2…
2019-12-14 00:12 UTC2019-12N021342-00563991012020-03-303f01610625f2…
2019-12-14 00:12 UTC2019-12N021342-00663991012020-03-303f01610625f2…
2019-12-14 00:12 UTC2019-12N021342-00763991012020-03-303f01610625f2…

Reported adverse events (FAERS/openFDA)#

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