FDA.reportPublic FDA data

XYOSTED

Product NDC
54436-275
11-digit product format
544360275
Labeler code
54436
Product ID
54436-275_c8d74eb6-fa94-446a-8307-091436a536dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
testosterone enanthate
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Antares Pharma, Inc.
Application
NDA209863
Marketing category
NDA
Marketing start
2018-11-15
Substance
TESTOSTERONE ENANTHATE
Active strength
75 mg/.5mL
Pharmacologic classes
Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule
CIII
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N209863-001XYOSTED (AUTOINJECTOR)TESTOSTERONE ENANTHATE50MG/0.5ML (50MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-28
N209863-002XYOSTED (AUTOINJECTOR)TESTOSTERONE ENANTHATE75MG/0.5ML (75MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-28
N209863-003XYOSTED (AUTOINJECTOR)TESTOSTERONE ENANTHATE100MG/0.5ML (100MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-28

Orange Book patents#

Current patent rows page 1 of 1 · 69 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209863-001104785602026-01-24Drug product2020-06-11
N209863-001114464412026-01-24Drug product2022-10-07
N209863-00185625642026-01-24Drug product2018-10-24
N209863-00191802592026-01-24Drug product2018-10-24
N209863-00195331022026-01-24Drug product2018-10-24
N209863-00196299592026-01-24Drug product2018-10-24
N209863-00180213352026-10-04Drug product2018-10-24
N209863-001114977532030-03-19Drug product2022-12-14
N209863-001102791312031-07-31Drug product2020-06-11
N209863-001103576092031-08-21Drug product2020-06-11
N209863-001109058272031-08-21Drug product2021-03-02
N209863-001114464402031-08-21Drug product2022-10-07
N209863-001108210722033-06-04U-2418Drug product2020-11-23
N209863-001118448042033-06-04U-24182024-01-18
N209863-001108817982034-02-11Drug product2021-02-04
N209863-001111607512034-10-07U-2418Drug product2022-01-06
N209863-001102386622035-02-19U-2418Drug product2020-06-11
N209863-001109127822035-02-19U-2418Drug product2021-03-02
N209863-001118134352035-02-25Drug product2023-11-22
N209863-001126294832035-08-07Drug product2026-06-04
N209863-001111919082035-10-18Drug product2022-01-06
N209863-00197443022035-11-19Drug product2018-10-24
N209863-00199501252036-09-04U-2418Drug product2018-10-24
N209863-002104785602026-01-24Drug product2020-06-11
N209863-002114464412026-01-24Drug product2022-10-07
N209863-00285625642026-01-24Drug product2018-10-24
N209863-00291802592026-01-24Drug product2018-10-24
N209863-00295331022026-01-24Drug product2018-10-24
N209863-00296299592026-01-24Drug product2018-10-24
N209863-00280213352026-10-04Drug product2018-10-24
N209863-002114977532030-03-19Drug product2022-12-14
N209863-002102791312031-07-31Drug product2020-06-11
N209863-002103576092031-08-21Drug product2020-06-11
N209863-002109058272031-08-21Drug product2021-03-02
N209863-002114464402031-08-21Drug product2022-10-07
N209863-002108210722033-06-04U-2418Drug product2020-11-23
N209863-002118448042033-06-04U-24182024-01-18
N209863-002108817982034-02-11Drug product2021-02-04
N209863-002111607512034-10-07U-2418Drug product2022-01-06
N209863-002102386622035-02-19U-2418Drug product2020-06-11
N209863-002109127822035-02-19U-2418Drug product2021-03-02
N209863-002118134352035-02-25Drug product2023-11-22
N209863-002126294832035-08-07Drug product2026-06-04
N209863-002111919082035-10-18Drug product2022-01-06
N209863-00297443022035-11-19Drug product2018-10-24
N209863-00299501252036-09-04U-2418Drug product2018-10-24
N209863-003104785602026-01-24Drug product2020-06-11
N209863-003114464412026-01-24Drug product2022-10-07
N209863-00385625642026-01-24Drug product2018-10-24
N209863-00391802592026-01-24Drug product2018-10-24
N209863-00395331022026-01-24Drug product2018-10-24
N209863-00396299592026-01-24Drug product2018-10-24
N209863-00380213352026-10-04Drug product2018-10-24
N209863-003114977532030-03-19Drug product2022-12-14
N209863-003102791312031-07-31Drug product2020-06-11
N209863-003103576092031-08-21Drug product2020-06-11
N209863-003109058272031-08-21Drug product2021-03-02
N209863-003114464402031-08-21Drug product2022-10-07
N209863-003108210722033-06-04U-2418Drug product2020-11-23
N209863-003118448042033-06-04U-24182024-01-18
N209863-003108817982034-02-11Drug product2021-02-04
N209863-003111607512034-10-07U-2418Drug product2022-01-06
N209863-003102386622035-02-19U-2418Drug product2020-06-11
N209863-003109127822035-02-19U-2418Drug product2021-03-02
N209863-003118134352035-02-25Drug product2023-11-22
N209863-003126294832035-08-07Drug product2026-06-04
N209863-003111919082035-10-18Drug product2022-01-06
N209863-00397443022035-11-19Drug product2018-10-24
N209863-00399501252036-09-04U-2418Drug product2018-10-24

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N209863-001XYOSTED (AUTOINJECTOR)50MG/0.5ML (50MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-002XYOSTED (AUTOINJECTOR)75MG/0.5ML (75MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-003XYOSTED (AUTOINJECTOR)100MG/0.5ML (100MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209863-001XYOSTED (AUTOINJECTOR)50MG/0.5ML (50MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209863-002XYOSTED (AUTOINJECTOR)75MG/0.5ML (75MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209863-003XYOSTED (AUTOINJECTOR)100MG/0.5ML (100MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209863-001XYOSTED (AUTOINJECTOR)50MG/0.5ML (50MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209863-002XYOSTED (AUTOINJECTOR)75MG/0.5ML (75MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209863-003XYOSTED (AUTOINJECTOR)100MG/0.5ML (100MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N209863-001XYOSTED (AUTOINJECTOR)50MG/0.5ML (50MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209863-002XYOSTED (AUTOINJECTOR)75MG/0.5ML (75MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209863-003XYOSTED (AUTOINJECTOR)100MG/0.5ML (100MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209863-001XYOSTED (AUTOINJECTOR)50MG/0.5ML (50MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209863-002XYOSTED (AUTOINJECTOR)75MG/0.5ML (75MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209863-003XYOSTED (AUTOINJECTOR)100MG/0.5ML (100MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209863-001XYOSTED (AUTOINJECTOR)50MG/0.5ML (50MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209863-002XYOSTED (AUTOINJECTOR)75MG/0.5ML (75MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209863-003XYOSTED (AUTOINJECTOR)100MG/0.5ML (100MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209863-001XYOSTED (AUTOINJECTOR)50MG/0.5ML (50MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209863-002XYOSTED (AUTOINJECTOR)75MG/0.5ML (75MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209863-003XYOSTED (AUTOINJECTOR)100MG/0.5ML (100MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209863-001XYOSTED (AUTOINJECTOR)50MG/0.5ML (50MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209863-002XYOSTED (AUTOINJECTOR)75MG/0.5ML (75MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209863-003XYOSTED (AUTOINJECTOR)100MG/0.5ML (100MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209863-001XYOSTED (AUTOINJECTOR)50MG/0.5ML (50MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209863-002XYOSTED (AUTOINJECTOR)75MG/0.5ML (75MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209863-003XYOSTED (AUTOINJECTOR)100MG/0.5ML (100MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209863-001XYOSTED (AUTOINJECTOR)50MG/0.5ML (50MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209863-002XYOSTED (AUTOINJECTOR)75MG/0.5ML (75MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209863-003XYOSTED (AUTOINJECTOR)100MG/0.5ML (100MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209863-001XYOSTED (AUTOINJECTOR)50MG/0.5ML (50MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N209863-002XYOSTED (AUTOINJECTOR)75MG/0.5ML (75MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N209863-003XYOSTED (AUTOINJECTOR)100MG/0.5ML (100MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209863-001XYOSTED (AUTOINJECTOR)50MG/0.5ML (50MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209863-002XYOSTED (AUTOINJECTOR)75MG/0.5ML (75MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209863-003XYOSTED (AUTOINJECTOR)100MG/0.5ML (100MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209863-001XYOSTED (AUTOINJECTOR)50MG/0.5ML (50MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209863-002XYOSTED (AUTOINJECTOR)75MG/0.5ML (75MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209863-003XYOSTED (AUTOINJECTOR)100MG/0.5ML (100MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209863-001XYOSTED (AUTOINJECTOR)50MG/0.5ML (50MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-09-281e350fbaab3a…

Observed Orange Book patent history#

Patent history page 1 of 62 · 2,460 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N209863-001104785602026-01-24Drug product2020-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-001114464412026-01-24Drug product2022-10-07caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-00185625642026-01-24Drug product2018-10-24caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-00191802592026-01-24Drug product2018-10-24caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-00195331022026-01-24Drug product2018-10-24caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-00196299592026-01-24Drug product2018-10-24caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-00180213352026-10-04Drug product2018-10-24caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-001114977532030-03-19Drug product2022-12-14caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-001102791312031-07-31Drug product2020-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-001103576092031-08-21Drug product2020-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-001109058272031-08-21Drug product2021-03-02caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-001114464402031-08-21Drug product2022-10-07caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-001108210722033-06-04U-2418Drug product2020-11-23caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-001118448042033-06-04U-24182024-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-001108817982034-02-11Drug product2021-02-04caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-001111607512034-10-07U-2418Drug product2022-01-06caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-001102386622035-02-19U-2418Drug product2020-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-001109127822035-02-19U-2418Drug product2021-03-02caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-001118134352035-02-25Drug product2023-11-22caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-001126294832035-08-07Drug product2026-06-04caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-001111919082035-10-18Drug product2022-01-06caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-00197443022035-11-19Drug product2018-10-24caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-00199501252036-09-04U-2418Drug product2018-10-24caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-002104785602026-01-24Drug product2020-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-002114464412026-01-24Drug product2022-10-07caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-00285625642026-01-24Drug product2018-10-24caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-00291802592026-01-24Drug product2018-10-24caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-00295331022026-01-24Drug product2018-10-24caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-00296299592026-01-24Drug product2018-10-24caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-00280213352026-10-04Drug product2018-10-24caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-002114977532030-03-19Drug product2022-12-14caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-002102791312031-07-31Drug product2020-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-002103576092031-08-21Drug product2020-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-002109058272031-08-21Drug product2021-03-02caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-002114464402031-08-21Drug product2022-10-07caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-002108210722033-06-04U-2418Drug product2020-11-23caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-002118448042033-06-04U-24182024-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-002108817982034-02-11Drug product2021-02-04caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-002111607512034-10-07U-2418Drug product2022-01-06caaa826d4ba7…
2026-08-18 06:07:402026-07N209863-002102386622035-02-19U-2418Drug product2020-06-11caaa826d4ba7…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N209863-001NP2021-09-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N209863-002NP2021-09-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N209863-003NP2021-09-2874a2ff9319b5…
2021-12-28 21:50 UTC2021-12N209863-001NP2021-09-28782e0a99824c…
2021-12-28 21:50 UTC2021-12N209863-002NP2021-09-28782e0a99824c…
2021-12-28 21:50 UTC2021-12N209863-003NP2021-09-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209863-001NP2021-09-2887673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209863-002NP2021-09-2887673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209863-003NP2021-09-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N209863-001NP2021-09-285aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N209863-002NP2021-09-285aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N209863-003NP2021-09-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N209863-001NP2021-09-288869cabd3fbd…
2020-12-22 03:56 UTC2020-12N209863-002NP2021-09-288869cabd3fbd…
2020-12-22 03:56 UTC2020-12N209863-003NP2021-09-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N209863-001NP2021-09-28c0c555d07b60…
2020-11-12 02:37 UTC2020-11N209863-002NP2021-09-28c0c555d07b60…
2020-11-12 02:37 UTC2020-11N209863-003NP2021-09-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N209863-001NP2021-09-283f01610625f2…
2019-12-14 00:12 UTC2019-12N209863-002NP2021-09-283f01610625f2…
2019-12-14 00:12 UTC2019-12N209863-003NP2021-09-283f01610625f2…
2019-09-15 20:21 UTC2019-09N209863-001NP2021-09-28b00525d2431f…
2019-09-15 20:21 UTC2019-09N209863-002NP2021-09-28b00525d2431f…
2019-09-15 20:21 UTC2019-09N209863-003NP2021-09-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N209863-001NP2021-09-28ea99ee380514…
2019-07-19 19:46 UTC2019-07N209863-002NP2021-09-28ea99ee380514…
2019-07-19 19:46 UTC2019-07N209863-003NP2021-09-28ea99ee380514…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TESTOSTERONE ENANTHATE75 mg/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7Z6522T8N9Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2099681Internal RxNorm lookup
2099686Internal RxNorm lookup
2099689Internal RxNorm lookup
2099691Internal RxNorm lookup
2099695Internal RxNorm lookup
2099697Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8a3d204c-be26-49e0-8599-0ac12a272e81Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2db4fc38-a116-b0ab-3dae-57df54e5f212Product name220250121
386d1b2a-e9b7-0c83-111f-2a77b92895b3Product name520240422
7d55b53c-798b-47ae-992b-3921493a8303Product name120230322
8d753fd6-75b2-4f12-bcbf-339392960afaProduct name120230303
4fbda828-a5be-46fe-83ec-a88da4359919Product name120230104
93cc9bee-8bdc-273d-ec7f-c2c52535317aProduct name720210902
a6389cd1-36d1-4b5c-9934-1139bee93605Product name520210601
f4f0889f-ee8b-471f-9a37-02a035280637Product name120200122
09e1afd3-f431-4380-82c5-438884c25615Product name120190111
a6389cd1-36d1-4b5c-9934-1139bee93605Product name320171212
502efed8-01a5-ef6a-61c6-fe8302b6e26bProduct name220171113
8b700cfd-17dd-41a2-90f5-a80ae8a989a2Product name120171113
9ce0e503-4ae7-2c6a-39ae-85285c29db68Product name220171113
96bdf4b3-71cd-433d-9723-89e50f852992Product name120150810
ed2e617f-f28a-1df1-f9fc-c79702f31271Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54436-275-01XYOSTED1 in 1 CARTONINJECTION116
54436-275-02XYOSTED0.5 mL in 1 SYRINGEINJECTION0.516
54436-275-03XYOSTED0.5 mL in 1 SYRINGEINJECTION0.516
54436-275-04XYOSTED4 in 1 CARTONINJECTION416
54436-275-05XYOSTED1 in 1 CARTONINJECTION116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54436-275-02ML - Milliliter54436-275e567c8ad-763f-4f81-99ec-d910f06f5afc12018-11-06
54436-275-04ML - Milliliter54436-27559c7aef0-97b9-4886-946d-63b76f13930712018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54436-275XYOSTED (TESTOSTERONE ENANTHATE) INJECTION [ANTARES PHARMA, INC.]12Current NDC, Legacy NDC, 5 package rows20250406_8a3d204c-be26-49e0-8599-0ac12a272e81.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XYOSTEDTESTOSTERONE ENANTHATEAntares Pharma, Inc.8a3d204c-be26-49e0-8599-0ac12a272e812025-07-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 209863
application number: NDA209863
ndc (product): 54436-275

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2099681testosterone enanthate 100 MG in 0.5 ML Auto-InjectorPSN8a3d204c-be26-49e0-8599-0ac12a272e8116
2099689testosterone enanthate 50 MG in 0.5 ML Auto-InjectorPSN8a3d204c-be26-49e0-8599-0ac12a272e8116
2099695testosterone enanthate 75 MG in 0.5 ML Auto-InjectorPSN8a3d204c-be26-49e0-8599-0ac12a272e8116
2099686XYOSTED 100 MG in 0.5 ML Auto-InjectorPSN8a3d204c-be26-49e0-8599-0ac12a272e8116
2099691XYOSTED 50 MG in 0.5 ML Auto-InjectorPSN8a3d204c-be26-49e0-8599-0ac12a272e8116
2099697XYOSTED 75 MG in 0.5 ML Auto-InjectorPSN8a3d204c-be26-49e0-8599-0ac12a272e8116
20996910.5 ML testosterone enanthate 100 MG/ML Auto-Injector [Xyosted]SBD8a3d204c-be26-49e0-8599-0ac12a272e8116
20996970.5 ML testosterone enanthate 150 MG/ML Auto-Injector [Xyosted]SBD8a3d204c-be26-49e0-8599-0ac12a272e8116
20996860.5 ML testosterone enanthate 200 MG/ML Auto-Injector [Xyosted]SBD8a3d204c-be26-49e0-8599-0ac12a272e8116
20996890.5 ML testosterone enanthate 100 MG/ML Auto-InjectorSCD8a3d204c-be26-49e0-8599-0ac12a272e8116
20996950.5 ML testosterone enanthate 150 MG/ML Auto-InjectorSCD8a3d204c-be26-49e0-8599-0ac12a272e8116
20996810.5 ML testosterone enanthate 200 MG/ML Auto-InjectorSCD8a3d204c-be26-49e0-8599-0ac12a272e8116
20996910.5 ML Xyosted 100 MG/ML Auto-InjectorSY8a3d204c-be26-49e0-8599-0ac12a272e8116
20996970.5 ML Xyosted 150 MG/ML Auto-InjectorSY8a3d204c-be26-49e0-8599-0ac12a272e8116
20996860.5 ML Xyosted 200 MG/ML Auto-InjectorSY8a3d204c-be26-49e0-8599-0ac12a272e8116
2099681testosterone enanthate 100 MG per 0.5 ML Auto-InjectorSY8a3d204c-be26-49e0-8599-0ac12a272e8116
2099689testosterone enanthate 50 MG per 0.5 ML Auto-InjectorSY8a3d204c-be26-49e0-8599-0ac12a272e8116
2099695testosterone enanthate 75 MG per 0.5 ML Auto-InjectorSY8a3d204c-be26-49e0-8599-0ac12a272e8116
2099686Xyosted 100 MG per 0.5 ML Auto-InjectorSY8a3d204c-be26-49e0-8599-0ac12a272e8116
2099691Xyosted 50 MG per 0.5 ML Auto-InjectorSY8a3d204c-be26-49e0-8599-0ac12a272e8116
2099697XYOSTED 75 MG per 0.5 ML Auto-InjectorSY8a3d204c-be26-49e0-8599-0ac12a272e8116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54436-275-01544360275011 SYRINGE in 1 CARTON (54436-275-01) / .5 mL in 1 SYRINGE (54436-275-03) 1 syringe2018-11-150000-00-00YesNoCurrent
54436-275-02544360275020.5 mL in 1 SYRINGE0.5 mlHistorical
54436-275-03544360275030.5 mL in 1 SYRINGE0.5 mlHistorical
54436-275-04544360275044 SYRINGE in 1 CARTON (54436-275-04) / .5 mL in 1 SYRINGE (54436-275-02) 4 syringe2018-11-150000-00-00NoNoCurrent
54436-275-05544360275051 SYRINGE in 1 CARTON (54436-275-05) / .5 mL in 1 SYRINGE (54436-275-02) 1 syringe2024-01-08NoNoCurrent