FDA.reportPublic FDA data

Ozempic

Product NDC
50090-8027
11-digit product format
500908027
Labeler code
50090
Product ID
50090-8027_4b9bdfa7-1075-45cd-baac-66632beb38df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
semaglutide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
NDA209637
Marketing category
NDA
Marketing start
2022-10-07
Substance
SEMAGLUTIDE
Active strength
.68 mg/mL
Pharmacologic classes
GLP-1 Receptor Agonist [EPC]; Glucagon-Like Peptide 1 [CS]; Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N209637-001OZEMPICSEMAGLUTIDE2MG/1.5ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD2017-12-05
N209637-002OZEMPICSEMAGLUTIDE4MG/3ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-04-09
N209637-003OZEMPICSEMAGLUTIDE8MG/3ML (2.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-03-28
N209637-004OZEMPICSEMAGLUTIDE2MG/3ML (0.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-06
N209637-005OZEMPICSEMAGLUTIDE0.25MG/0.5ML (0.25MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-05-05
N209637-006OZEMPICSEMAGLUTIDE0.5MG/0.5ML (0.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-05-05
N209637-007OZEMPICSEMAGLUTIDE1MG/0.5ML (1MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-05-05

Orange Book patents#

Current patent rows page 1 of 2 · 92 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209637-001103576162026-01-20Drug product, Delist requested2019-08-08
N209637-001103766522026-01-20Drug product, Delist requested2019-09-13
N209637-00191080022026-01-20Drug product, Delist requested2017-12-20
N209637-00196161802026-01-20Drug product, Delist requested2018-08-17
N209637-00198617572026-01-20Drug product, Delist requested2018-08-17
N209637-00185361222026-03-20U-2202Drug substance, Drug product2017-12-20
N209637-001102201552026-07-17Drug product, Delist requested2019-04-04
N209637-001110970632026-07-17Drug product, Delist requested2021-09-21
N209637-00189203832026-07-17Drug product, Delist requested2017-12-20
N209637-00197759532026-07-17Drug product, Delist requested2017-12-20
N209637-001RE463632026-08-03Drug product, Delist requested2017-12-20
N209637-00196876112027-02-27Drug product, Delist requested2017-12-20
N209637-00194571542027-09-29Drug product, Delist requested2017-12-20
N209637-00181293432031-12-05U-2202Drug substance, Drug product2017-12-20
N209637-00191322392032-02-01Drug product, Delist requested2017-12-20
N209637-001103354622033-06-21U-25802019-07-25
N209637-002103576162026-01-20Drug product, Delist requested2020-12-21
N209637-002103766522026-01-20Drug product, Delist requested2020-12-21
N209637-00291080022026-01-20Drug product, Delist requested2020-12-21
N209637-00296161802026-01-20Drug product, Delist requested2020-12-21
N209637-00298617572026-01-20Drug product, Delist requested2020-12-21
N209637-00285361222026-03-20U-2202Drug substance, Drug product2020-09-24
N209637-002102201552026-07-17Drug product, Delist requested2020-12-21
N209637-002110970632026-07-17Drug product, Delist requested2021-09-21
N209637-00289203832026-07-17Drug product, Delist requested2020-12-21
N209637-00297759532026-07-17Drug product, Delist requested2020-12-21
N209637-002RE463632026-08-03Drug product, Delist requested2020-12-21
N209637-00296876112027-02-27Drug product, Delist requested2020-12-21
N209637-00294571542027-09-29Drug product, Delist requested2020-12-21
N209637-00281293432031-12-05U-2202Drug substance, Drug product2020-09-24
N209637-00291322392032-02-01Drug product, Delist requested2020-12-21
N209637-002103354622033-06-21U-25802020-09-24
N209637-002125695432037-04-28U-44462026-03-31
N209637-002122959882038-10-10U-18522026-06-23
N209637-003103576162026-01-20Drug product, Delist requested2022-04-29
N209637-003103766522026-01-20Drug product, Delist requested2022-04-29
N209637-00391080022026-01-20Drug product, Delist requested2022-04-29
N209637-00396161802026-01-20Drug product, Delist requested2022-04-29
N209637-00398617572026-01-20Drug product, Delist requested2022-04-29
N209637-00385361222026-03-20U-3355Drug substance, Drug product2022-04-29
N209637-003102201552026-07-17Drug product, Delist requested2022-04-29
N209637-003110970632026-07-17Drug product, Delist requested2022-04-29
N209637-00389203832026-07-17Drug product, Delist requested2022-04-29
N209637-00397759532026-07-17Drug product, Delist requested2022-04-29
N209637-003RE463632026-08-03Drug product, Delist requested2022-04-29
N209637-00396876112027-02-27Drug product, Delist requested2022-04-29
N209637-00394571542027-09-29Drug product, Delist requested2022-04-29
N209637-00381293432031-12-05U-3355Drug substance, Drug product2022-04-29
N209637-00391322392032-02-01Drug product, Delist requested2022-04-29
N209637-003125695432037-04-28U-44462026-03-31
N209637-003122959882038-10-10U-26282025-05-29
N209637-004103576162026-01-20Drug product, Delist requested2022-11-14
N209637-004103766522026-01-20Drug product, Delist requested2022-11-14
N209637-00491080022026-01-20Drug product, Delist requested2022-11-14
N209637-00496161802026-01-20Drug product, Delist requested2022-11-14
N209637-00498617572026-01-20Drug product, Delist requested2022-11-14
N209637-00485361222026-03-20U-3469Drug substance, Drug product2022-11-14
N209637-004102201552026-07-17Drug product, Delist requested2022-11-14
N209637-004110970632026-07-17Drug product, Delist requested2022-11-14
N209637-00489203832026-07-17Drug product, Delist requested2022-11-14
N209637-00497759532026-07-17Drug product, Delist requested2022-11-14
N209637-004RE463632026-08-03Drug product, Delist requested2022-11-14
N209637-00496876112027-02-27Drug product, Delist requested2022-11-14
N209637-00494571542027-09-29Drug product, Delist requested2022-11-14
N209637-00481293432031-12-05U-3469Drug substance, Drug product2022-11-14
N209637-00491322392032-02-01Drug product, Delist requested2022-11-14
N209637-004103354622033-06-21U-2580Drug product2022-11-14
N209637-004125695432037-04-28U-44462026-03-31
N209637-004122959882038-10-10U-18522026-06-23
N209637-00581293432031-12-05U-3355Drug substance, Drug product2026-06-23
N209637-005125695432037-04-28U-44462026-06-23
N209637-005108886052038-08-24U-1852Drug product2026-06-23
N209637-005117521982038-08-24U-1852Drug product2026-06-23
N209637-005122140172038-08-24U-1852Drug product2026-06-23
N209637-005113181912041-02-17U-1852Drug product2026-06-23
N209637-005113181912041-02-17U-4561Drug product2026-06-23
N209637-00681293432031-12-05U-3355Drug substance, Drug product2026-06-23
N209637-006125695432037-04-28U-44462026-06-23
N209637-006108886052038-08-24U-1852Drug product2026-06-23
N209637-006117521982038-08-24U-1852Drug product2026-06-23

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N209637-001I-9612028-01-28
N209637-002I-9612028-01-28
N209637-003I-9612028-01-28
N209637-004I-9612028-01-28

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 · 135 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N209637-001OZEMPIC2MG/1.5ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD2017-12-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-002OZEMPIC4MG/3ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-04-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-003OZEMPIC8MG/3ML (2.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-004OZEMPIC2MG/3ML (0.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209637-001OZEMPIC2MG/1.5ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD2017-12-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209637-002OZEMPIC4MG/3ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-04-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209637-003OZEMPIC8MG/3ML (2.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-03-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209637-004OZEMPIC2MG/3ML (0.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08N209637-001OZEMPIC2MG/1.5ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2017-12-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209637-002OZEMPIC4MG/3ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-04-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209637-003OZEMPIC8MG/3ML (2.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-03-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209637-004OZEMPIC2MG/3ML (0.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209637-001OZEMPIC2MG/1.5ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2017-12-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209637-002OZEMPIC4MG/3ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-04-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209637-003OZEMPIC8MG/3ML (2.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-03-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209637-004OZEMPIC2MG/3ML (0.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209637-001OZEMPIC2MG/1.5ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2017-12-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209637-002OZEMPIC4MG/3ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-04-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209637-003OZEMPIC8MG/3ML (2.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-03-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209637-004OZEMPIC2MG/3ML (0.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209637-001OZEMPIC2MG/1.5ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2017-12-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209637-002OZEMPIC4MG/3ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-04-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209637-003OZEMPIC8MG/3ML (2.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-03-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209637-004OZEMPIC2MG/3ML (0.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209637-001OZEMPIC2MG/1.5ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2017-12-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209637-002OZEMPIC4MG/3ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-04-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209637-003OZEMPIC8MG/3ML (2.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-03-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209637-004OZEMPIC2MG/3ML (0.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209637-001OZEMPIC2MG/1.5ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2017-12-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209637-002OZEMPIC4MG/3ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-04-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209637-003OZEMPIC8MG/3ML (2.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-03-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209637-004OZEMPIC2MG/3ML (0.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209637-001OZEMPIC2MG/1.5ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2017-12-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209637-002OZEMPIC4MG/3ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-04-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209637-003OZEMPIC8MG/3ML (2.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-03-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209637-004OZEMPIC2MG/3ML (0.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209637-001OZEMPIC2MG/1.5ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2017-12-05d06236e962d9…
2024-10-29 15:01 UTC2024-10N209637-002OZEMPIC4MG/3ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-04-09d06236e962d9…
2024-10-29 15:01 UTC2024-10N209637-003OZEMPIC8MG/3ML (2.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-03-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N209637-004OZEMPIC2MG/3ML (0.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-06d06236e962d9…

Observed Orange Book patent history#

Patent history page 1 of 69 · 2,740 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N209637-001103576162026-01-20Drug product, Delist requested2019-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-001103766522026-01-20Drug product, Delist requested2019-09-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-00191080022026-01-20Drug product, Delist requested2017-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-00196161802026-01-20Drug product, Delist requested2018-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-00198617572026-01-20Drug product, Delist requested2018-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-00185361222026-03-20U-2202Drug substance, Drug product2017-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-001102201552026-07-17Drug product, Delist requested2019-04-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-001110970632026-07-17Drug product, Delist requested2021-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-00189203832026-07-17Drug product, Delist requested2017-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-00197759532026-07-17Drug product, Delist requested2017-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-001RE463632026-08-03Drug product, Delist requested2017-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-00196876112027-02-27Drug product, Delist requested2017-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-00194571542027-09-27Drug product, Delist requested2017-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-00181293432031-12-05U-2202Drug substance, Drug product2017-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-00191322392032-02-01Drug product, Delist requested2017-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-001103354622033-06-21U-25802019-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-002103576162026-01-20Drug product, Delist requested2020-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-002103766522026-01-20Drug product, Delist requested2020-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-00291080022026-01-20Drug product, Delist requested2020-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-00296161802026-01-20Drug product, Delist requested2020-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-00298617572026-01-20Drug product, Delist requested2020-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-00285361222026-03-20U-2202Drug substance, Drug product2020-09-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-002102201552026-07-17Drug product, Delist requested2020-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-002110970632026-07-17Drug product, Delist requested2021-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-00289203832026-07-17Drug product, Delist requested2020-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-00297759532026-07-17Drug product, Delist requested2020-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-002RE463632026-08-03Drug product, Delist requested2020-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-00296876112027-02-27Drug product, Delist requested2020-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-00294571542027-09-29Drug product, Delist requested2020-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-00281293432031-12-05U-2202Drug substance, Drug product2020-09-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-00291322392032-02-01Drug product, Delist requested2020-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-002103354622033-06-21U-25802020-09-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-003103576162026-01-20Drug product, Delist requested2022-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-003103766522026-01-20Drug product, Delist requested2022-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-00391080022026-01-20Drug product, Delist requested2022-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-00396161802026-01-20Drug product, Delist requested2022-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-00398617572026-01-20Drug product, Delist requested2022-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-00385361222026-03-20U-3355Drug substance, Drug product2022-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-003102201552026-07-17Drug product, Delist requested2022-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-003110970632026-07-17Drug product, Delist requested2022-04-29011fe1cb6892…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 124 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N209637-001I-9612028-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-002I-9612028-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-003I-9612028-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209637-004I-9612028-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209637-001I-9612028-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209637-002I-9612028-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209637-003D-1852025-03-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209637-003I-9612028-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209637-004I-9612028-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N209637-001I-9612028-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209637-002I-9612028-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209637-003D-1852025-03-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209637-003I-9612028-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209637-004I-9612028-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209637-001I-9612028-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209637-002I-9612028-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209637-003D-1852025-03-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209637-003I-9612028-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209637-004I-9612028-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209637-003D-1852025-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209637-003D-1852025-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209637-003D-1852025-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209637-003D-1852025-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209637-003D-1852025-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209637-003D-1852025-03-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209637-003D-1852025-03-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209637-003D-1852025-03-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209637-003D-1852025-03-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209637-003D-1852025-03-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209637-001NCE2022-12-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209637-001I-8222023-01-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209637-002NCE2022-12-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209637-002I-8222023-01-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209637-003NCE2022-12-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209637-003D-1852025-03-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209637-001NCE2022-12-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N209637-001I-8222023-01-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N209637-002NCE2022-12-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N209637-002I-8222023-01-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209637-001NCE2022-12-054b0b4de00fa7…

Additional Listing Data#

Finished product
Yes
Brand name base
Ozempic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SEMAGLUTIDE.68 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
53AXN4NNHXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2619152Internal RxNorm lookup
2619154Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
42bdd912-2393-44c4-b7e0-47672ca28991Available on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OzempicSEMAGLUTIDEA-S Medication Solutions42bdd912-2393-44c4-b7e0-47672ca289912026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 209637
application number: NDA209637
ndc (product): 50090-8027
OzempicSEMAGLUTIDEA-S Medication Solutions979e4df4-0597-48ea-b51c-0f699fa6d1662023-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 209637
application number: NDA209637
OZEMPICSEMAGLUTIDEA-S Medication Solutionse6da837c-0da0-41d6-973c-5559bf7643672023-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 209637
application number: NDA209637

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleStatus
50090-8027-0500908027001 SYRINGE, PLASTIC in 1 CARTON (50090-8027-0) / 3 mL in 1 SYRINGE, PLASTIC2026-07-290Current