FDA.reportPublic FDA data

Ozempic

Product NDC
0169-4130
11-digit product format
001694130
Labeler code
0169
Product ID
0169-4130_852fff2d-704e-4b01-9244-439a28094202
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
semaglutide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Novo Nordisk Pharmaceutical Industries, LP
Application
NDA209637
Marketing category
NDA
Marketing start
2020-09-30
Substance
SEMAGLUTIDE
Active strength
1.34 mg/mL
Pharmacologic classes
GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 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 · 142 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N209637-001OZEMPIC2MG/1.5ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD2017-12-05caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-002OZEMPIC4MG/3ML (1.34MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-04-09caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-003OZEMPIC8MG/3ML (2.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-004OZEMPIC2MG/3ML (0.68MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-005OZEMPIC0.25MG/0.5ML (0.25MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-05-05caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-006OZEMPIC0.5MG/0.5ML (0.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-05-05caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-007OZEMPIC1MG/0.5ML (1MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-05-05caaa826d4ba7…
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…

Observed Orange Book patent history#

Patent history page 1 of 71 · 2,832 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N209637-001103576162026-01-20Drug product, Delist requested2019-08-08caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-001103766522026-01-20Drug product, Delist requested2019-09-13caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00191080022026-01-20Drug product, Delist requested2017-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00196161802026-01-20Drug product, Delist requested2018-08-17caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00198617572026-01-20Drug product, Delist requested2018-08-17caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00185361222026-03-20U-2202Drug substance, Drug product2017-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-001102201552026-07-17Drug product, Delist requested2019-04-04caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-001110970632026-07-17Drug product, Delist requested2021-09-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00189203832026-07-17Drug product, Delist requested2017-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00197759532026-07-17Drug product, Delist requested2017-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-001RE463632026-08-03Drug product, Delist requested2017-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00196876112027-02-27Drug product, Delist requested2017-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00194571542027-09-29Drug product, Delist requested2017-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00181293432031-12-05U-2202Drug substance, Drug product2017-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00191322392032-02-01Drug product, Delist requested2017-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-001103354622033-06-21U-25802019-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-002103576162026-01-20Drug product, Delist requested2020-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-002103766522026-01-20Drug product, Delist requested2020-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00291080022026-01-20Drug product, Delist requested2020-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00296161802026-01-20Drug product, Delist requested2020-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00298617572026-01-20Drug product, Delist requested2020-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00285361222026-03-20U-2202Drug substance, Drug product2020-09-24caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-002102201552026-07-17Drug product, Delist requested2020-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-002110970632026-07-17Drug product, Delist requested2021-09-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00289203832026-07-17Drug product, Delist requested2020-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00297759532026-07-17Drug product, Delist requested2020-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-002RE463632026-08-03Drug product, Delist requested2020-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00296876112027-02-27Drug product, Delist requested2020-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00294571542027-09-29Drug product, Delist requested2020-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00281293432031-12-05U-2202Drug substance, Drug product2020-09-24caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00291322392032-02-01Drug product, Delist requested2020-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-002103354622033-06-21U-25802020-09-24caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-002125695432037-04-28U-44462026-03-31caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-002122959882038-10-10U-18522026-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-003103576162026-01-20Drug product, Delist requested2022-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-003103766522026-01-20Drug product, Delist requested2022-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00391080022026-01-20Drug product, Delist requested2022-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00396161802026-01-20Drug product, Delist requested2022-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00398617572026-01-20Drug product, Delist requested2022-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-00385361222026-03-20U-3355Drug substance, Drug product2022-04-29caaa826d4ba7…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 128 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N209637-001I-9612028-01-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-002I-9612028-01-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-003I-9612028-01-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209637-004I-9612028-01-28caaa826d4ba7…
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…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SEMAGLUTIDE1.34 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9dd2abc7-744f-456b-a273-dec083824bd8Product name220240229
487bac84-7c5b-40cf-afd2-8b9674d4648eProduct name120220118
21318a8d-e167-4f44-9627-3daede9532ffProduct name120200227

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0169-4130-01Ozempic3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION319
0169-4130-13Ozempic1 in 1 CARTONINJECTION, SOLUTION119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-4130-01ML - Milliliter0169-41301151631f-9263-494a-8b94-fd72cb801bb612021-03-02
0169-4130-13ML - Milliliter0169-41305790671f-572f-4d8c-875a-aa6d631a6e2e12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-4130OZEMPIC (SEMAGLUTIDE) INJECTION, SOLUTION [NOVO NORDISK]16Current NDC, Legacy NDC, 2 package rows20250210_adec4fd2-6858-4c99-91d4-531f5f2a2d79.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 · 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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1991311OZEMPIC 2 MG in 1.5 ML Pen Injector, 0.25 or 0.5 MG DosePSNadec4fd2-6858-4c99-91d4-531f5f2a2d7919
1991317OZEMPIC 2 MG in 1.5 ML Pen Injector, 1 MG DosePSNadec4fd2-6858-4c99-91d4-531f5f2a2d7919
2619154OZEMPIC 2 MG in 3 ML Pen Injector, 0.25 or 0.5 MG DosePSNadec4fd2-6858-4c99-91d4-531f5f2a2d7919
2398842OZEMPIC 4 MG in 3 ML Pen InjectorPSNadec4fd2-6858-4c99-91d4-531f5f2a2d7919
2599365OZEMPIC 8 MG in 3 ML Pen InjectorPSNadec4fd2-6858-4c99-91d4-531f5f2a2d7919
1991306semaglutide 2 MG in 1.5 ML Pen Injector, 0.25 or 0.5 MG DosePSNadec4fd2-6858-4c99-91d4-531f5f2a2d7919
1991316semaglutide 2 MG in 1.5 ML Pen Injector, 1 MG DosePSNadec4fd2-6858-4c99-91d4-531f5f2a2d7919
2619152semaglutide 2 MG in 3 ML Pen Injector, 0.25 MG, 0.5 MG DosePSNadec4fd2-6858-4c99-91d4-531f5f2a2d7919
2398841semaglutide 4 MG in 3 ML Pen InjectorPSNadec4fd2-6858-4c99-91d4-531f5f2a2d7919
2599362semaglutide 8 MG in 3 ML Pen InjectorPSNadec4fd2-6858-4c99-91d4-531f5f2a2d7919
19913110.25 MG, 0.5 MG Dose 1.5 ML semaglutide 1.34 MG/ML Pen Injector [Ozempic]SBDadec4fd2-6858-4c99-91d4-531f5f2a2d7919
26191540.25 MG, 0.5 MG Dose 3 ML semaglutide 0.68 MG/ML Pen Injector [Ozempic]SBDadec4fd2-6858-4c99-91d4-531f5f2a2d7919
19913171 MG Dose 1.5 ML semaglutide 1.34 MG/ML Pen Injector [Ozempic]SBDadec4fd2-6858-4c99-91d4-531f5f2a2d7919
23988423 ML semaglutide 1.34 MG/ML Pen Injector [Ozempic]SBDadec4fd2-6858-4c99-91d4-531f5f2a2d7919
25993653 ML semaglutide 2.68 MG/ML Pen Injector [Ozempic]SBDadec4fd2-6858-4c99-91d4-531f5f2a2d7919
19913060.25 MG, 0.5 MG Dose 1.5 ML semaglutide 1.34 MG/ML Pen InjectorSCDadec4fd2-6858-4c99-91d4-531f5f2a2d7919
26191520.25 MG, 0.5 MG Dose 3 ML semaglutide 0.68 MG/ML Pen InjectorSCDadec4fd2-6858-4c99-91d4-531f5f2a2d7919
19913161 MG Dose 1.5 ML semaglutide 1.34 MG/ML Pen InjectorSCDadec4fd2-6858-4c99-91d4-531f5f2a2d7919
23988413 ML semaglutide 1.34 MG/ML Pen InjectorSCDadec4fd2-6858-4c99-91d4-531f5f2a2d7919
25993623 ML semaglutide 2.68 MG/ML Pen InjectorSCDadec4fd2-6858-4c99-91d4-531f5f2a2d7919
19913110.25 MG, 0.5 MG Dose 1.5 ML Ozempic 1.34 MG/ML Pen InjectorSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
26191540.25 MG, 0.5 MG Dose 3 ML Ozempic 0.68 MG/ML Pen InjectorSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
26191520.25 MG, 0.5 MG Dose semaglutide 2 MG per 3 ML Pen InjectorSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
19913171 MG Dose 1.5 ML Ozempic 1.34 MG/ML Pen InjectorSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
23988423 ML Ozempic 1.34 MG/ML Pen InjectorSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
1991311OZEMPIC 2 MG per 1.5 ML Pen Injector, 0.25 or 0.5 MG DoseSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
1991317OZEMPIC 2 MG per 1.5 ML Pen Injector, 1 MG DoseSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
2599365Ozempic 2.68 MG/ML per 3 ML Pen InjectorSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
2599365Ozempic 8 MG per 3 ML Pen InjectorSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
1991306semaglutide 2 MG per 1.5 ML Pen Injector, 0.25 or 0.5 MG DoseSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
1991316semaglutide 2 MG per 1.5 ML Pen Injector, 1 MG DoseSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
2599362semaglutide 2.68 MG/ML per 3 ML Pen InjectorSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
2398841semaglutide 4 MG in 3 ML Pen InjectorSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
2599362semaglutide 8 MG per 3 ML Pen InjectorSYadec4fd2-6858-4c99-91d4-531f5f2a2d7919
2398842OZEMPIC 4 MG in 3 ML Pen InjectorPSN979e4df4-0597-48ea-b51c-0f699fa6d1663
2398841semaglutide 4 MG in 3 ML Pen InjectorPSN979e4df4-0597-48ea-b51c-0f699fa6d1663
23988423 ML semaglutide 1.34 MG/ML Pen Injector [Ozempic]SBD979e4df4-0597-48ea-b51c-0f699fa6d1663
23988413 ML semaglutide 1.34 MG/ML Pen InjectorSCD979e4df4-0597-48ea-b51c-0f699fa6d1663
23988423 ML Ozempic 1.34 MG/ML Pen InjectorSY979e4df4-0597-48ea-b51c-0f699fa6d1663
2398841semaglutide 4 MG in 3 ML Pen InjectorSY979e4df4-0597-48ea-b51c-0f699fa6d1663

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0169-4130-01001694130013 mL in 1 SYRINGE, PLASTIC3 mlHistorical
0169-4130-13001694130131 SYRINGE, PLASTIC in 1 CARTON (0169-4130-13) / 3 mL in 1 SYRINGE, PLASTIC (0169-4130-01) 2021-01-030000-00-00NoNoCurrent