THYQUIDITY

Product NDC
81116-100
11-digit product format
811160100
Labeler code
81116
Product ID
81116-100_b868b9dc-73bf-37fe-e053-2995a90a6677
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
SOLUTION
Route
ORAL
Labeler
GALENICA S.A.
Application
NDA214047
Marketing category
NDA
Marketing start
2021-02-15
Marketing end
0000-00-00
Substance
LEVOTHYROXINE SODIUM
Active strength
100 ug/5mL
Pharmacologic classes
l-Thyroxine [EPC],Thyroxine [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N214047-001THYQUIDITYLEVOTHYROXINE SODIUM100MCG/5MLSOLUTION / ORALRLD, RS2020-11-30

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N214047-00190503072031-08-06Drug product2020-12-14

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-3084e616aacf4f…
2026-08-18 06:07:402026-07N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-304b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-3087673890dc5c…
2021-03-12 10:30 UTC2021-03N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-308869cabd3fbd…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-303f0d92c62455…
2023-05-13 08:27 UTC2023-05N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-30053a50430f4f…
2023-01-26 05:58 UTC2023-01N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-30cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N214047-001THYQUIDITY100MCG/5MLSOLUTION / ORALRLD, RS2020-11-30a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N214047-00190503072031-08-06Drug product2020-12-1484e616aacf4f…
2026-08-18 06:07:402026-07N214047-00190503072031-08-06Drug product2020-12-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N214047-00190503072031-08-06Drug product2020-12-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214047-00190503072031-08-06Drug product2020-12-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N214047-00190503072031-08-06Drug product2020-12-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214047-00190503072031-08-06Drug product2020-12-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214047-00190503072031-08-06Drug product2020-12-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214047-00190503072031-08-06Drug product2020-12-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214047-00190503072031-08-06Drug product2020-12-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214047-00190503072031-08-06Drug product2020-12-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214047-00190503072031-08-06Drug product2020-12-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214047-00190503072031-08-06Drug product2020-12-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214047-00190503072031-08-06Drug product2020-12-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214047-00190503072031-08-06Drug product2020-12-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214047-00190503072031-08-06Drug product2020-12-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N214047-00190503072031-08-06Drug product2020-12-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214047-00190503072031-08-06Drug product2020-12-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N214047-00190503072031-08-06Drug product2020-12-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N214047-00190503072031-08-06Drug product2020-12-144b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N214047-00190503072031-08-06Drug product2020-12-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N214047-00190503072031-08-06Drug product2020-12-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N214047-00190503072031-08-06Drug product2020-12-1487673890dc5c…
2021-03-12 10:30 UTC2021-03N214047-00190503072031-08-06Drug product2020-12-145aa47cf7b7d7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N214047-00190503072031-08-06Drug product2020-12-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N214047-00190503072031-08-06Drug product2020-12-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12N214047-00190503072031-08-06Drug product2020-12-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N214047-00190503072031-08-06Drug product2020-12-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N214047-00190503072031-08-06Drug product2020-12-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N214047-00190503072031-08-06Drug product2020-12-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N214047-00190503072031-08-06Drug product2020-12-143f0d92c62455…
2023-05-13 08:27 UTC2023-05N214047-00190503072031-08-06Drug product2020-12-14053a50430f4f…
2023-01-26 05:58 UTC2023-01N214047-00190503072031-08-06Drug product2020-12-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N214047-00190503072031-08-06Drug product2020-12-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N214047-00190503072031-08-06Drug product2020-12-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N214047-00190503072031-08-06Drug product2020-12-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N214047-00190503072031-08-06Drug product2020-12-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N214047-00190503072031-08-06Drug product2020-12-14a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THYQUIDITYLEVOTHYROXINE SODIUMOliva Therapeutics, LLC0c839877-50e4-455f-9b6c-462efb09cb962025-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 214047
application number: NDA214047