FDA.reportPublic FDA data

Otrexup

Product NDC
54436-020
11-digit product format
544360020
Labeler code
54436
Product ID
54436-020_2d07eb50-d314-a6a0-e063-6394a90ac970
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methotrexate
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Antares Pharma, Inc.
Application
NDA204824
Marketing category
NDA
Marketing start
2013-10-11
Marketing end
2027-04-30
Substance
METHOTREXATE
Active strength
20 mg/.4mL
Pharmacologic classes
Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag
No
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 · 14 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N204824-001OTREXUPMETHOTREXATE10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-11
N204824-002OTREXUPMETHOTREXATE15MG/0.4ML (15MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-11
N204824-003OTREXUPMETHOTREXATE20MG/0.4ML (20MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-11
N204824-004OTREXUPMETHOTREXATE25MG/0.4ML (25MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-11
N204824-005OTREXUPMETHOTREXATE7.5MG/0.4ML (7.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2014-11-07
N204824-006OTREXUPMETHOTREXATE12.5MG/0.4ML (12.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2016-03-24
N204824-007OTREXUPMETHOTREXATE17.5MG/0.4ML (17.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2016-03-24
N204824-008OTREXUPMETHOTREXATE22.5MG/0.4ML (22.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2016-03-24
N204824-009OTREXUP PFSMETHOTREXATE10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31
N204824-010OTREXUP PFSMETHOTREXATE15MG/0.6ML (15MG/0.6ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31
N204824-011OTREXUP PFSMETHOTREXATE17.5MG/0.7ML (17.5MG/0.7ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31
N204824-012OTREXUP PFSMETHOTREXATE20MG/0.8ML (20MG/0.8ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31
N204824-013OTREXUP PFSMETHOTREXATE22.5MG/0.9ML (22.5MG/0.9ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31
N204824-014OTREXUP PFSMETHOTREXATE25MG/ML (25MG/ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31

Orange Book patents#

Current patent rows page 1 of 2 · 120 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N204824-001114464412026-01-24Drug product2022-10-19
N204824-00185625642026-01-24Drug product2013-11-04
N204824-00195331022026-01-24Drug product2017-02-02
N204824-00196299592026-01-24Drug product2017-05-25
N204824-00180213352026-10-04Drug product2013-11-04
N204824-001107098442029-03-10Drug product2020-08-14
N204824-001116847232029-03-10Drug product2023-07-19
N204824-00198679492029-03-10Drug product2020-08-14
N204824-001114977532030-03-19Drug product2022-12-13
N204824-001123576422030-03-19Drug product2025-08-15
N204824-00184806312030-03-19U-1442Drug product2013-11-04
N204824-00185798652030-03-19U-1442Drug product2013-11-21
N204824-00189450632030-03-19U-1442Drug product2015-03-02
N204824-00194213332030-03-19U-1442Drug product2016-09-21
N204824-00188148342031-05-27Drug product2020-08-14
N204824-002114464412026-01-24Drug product2022-10-19
N204824-00285625642026-01-24Drug product2013-11-04
N204824-00295331022026-01-24Drug product2017-02-02
N204824-00296299592026-01-24Drug product2017-05-25
N204824-00280213352026-10-04Drug product2013-11-04
N204824-002107098442029-03-10Drug product2020-08-14
N204824-002116847232029-03-10Drug product2023-07-19
N204824-00298679492029-03-10Drug product2020-08-14
N204824-002114977532030-03-19Drug product2022-12-13
N204824-002123576422030-03-19Drug product2025-08-15
N204824-00284806312030-03-19U-1442Drug product
N204824-00285798652030-03-19U-1442Drug product2013-11-21
N204824-00289450632030-03-19U-1442Drug product2015-03-02
N204824-00294213332030-03-19U-1442Drug product2016-09-21
N204824-00288148342031-05-27Drug product2020-08-14
N204824-003114464412026-01-24Drug product2022-10-19
N204824-00385625642026-01-24Drug product2013-11-04
N204824-00395331022026-01-24Drug product2017-02-02
N204824-00396299592026-01-24Drug product2017-05-25
N204824-00380213352026-10-04Drug product2013-11-04
N204824-003107098442029-03-10Drug product2020-08-14
N204824-003116847232029-03-10Drug product2023-07-19
N204824-00398679492029-03-10Drug product2020-08-14
N204824-003114977532030-03-19Drug product2022-12-13
N204824-003123576422030-03-19Drug product2025-08-15
N204824-00384806312030-03-19U-1442Drug product
N204824-00385798652030-03-19U-1442Drug product2013-11-21
N204824-00389450632030-03-19U-1442Drug product2015-03-02
N204824-00394213332030-03-19U-1442Drug product2016-09-21
N204824-00388148342031-05-27Drug product2020-08-14
N204824-004114464412026-01-24Drug product2022-10-19
N204824-00485625642026-01-24Drug product2013-11-04
N204824-00495331022026-01-24Drug product2017-02-02
N204824-00496299592026-01-24Drug product2017-05-25
N204824-00480213352026-10-04Drug product2013-11-04
N204824-004107098442029-03-10Drug product2020-08-14
N204824-004116847232029-03-10Drug product2023-07-19
N204824-00498679492029-03-10Drug product2020-08-14
N204824-004114977532030-03-19Drug product2022-12-13
N204824-004123576422030-03-19Drug product2025-08-15
N204824-00484806312030-03-19U-1442Drug product
N204824-00485798652030-03-19U-1442Drug product2013-11-21
N204824-00489450632030-03-19U-1442Drug product2015-03-02
N204824-00494213332030-03-19U-1442Drug product2016-09-21
N204824-00488148342031-05-27Drug product2020-08-14
N204824-005114464412026-01-24Drug product2022-10-19
N204824-00585625642026-01-24Drug product2014-12-02
N204824-00595331022026-01-24Drug product2017-02-02
N204824-00596299592026-01-24Drug product2017-05-25
N204824-00580213352026-10-04Drug product2014-12-02
N204824-005107098442029-03-10Drug product2020-08-14
N204824-005116847232029-03-10Drug product2023-07-19
N204824-00598679492029-03-10Drug product2020-08-14
N204824-005114977532030-03-19Drug product2022-12-13
N204824-005123576422030-03-19Drug product2025-08-15
N204824-00584806312030-03-19U-1442Drug product2014-12-02
N204824-00585798652030-03-19U-1442Drug product2014-12-02
N204824-00589450632030-03-19U-1442Drug product2015-03-02
N204824-00594213332030-03-19U-1442Drug product2016-09-21
N204824-00588148342031-05-27Drug product2020-08-14
N204824-006114464412026-01-24Drug product2022-10-19
N204824-00685625642026-01-24Drug product2016-06-01
N204824-00695331022026-01-24Drug product2017-02-02
N204824-00696299592026-01-24Drug product2017-05-25
N204824-00680213352026-10-04Drug product2016-06-01

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 15 · 588 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N204824-001OTREXUP10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-11caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-002OTREXUP15MG/0.4ML (15MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-11caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-003OTREXUP20MG/0.4ML (20MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-11caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-004OTREXUP25MG/0.4ML (25MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-11caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-005OTREXUP7.5MG/0.4ML (7.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2014-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-006OTREXUP12.5MG/0.4ML (12.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2016-03-24caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-007OTREXUP17.5MG/0.4ML (17.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2016-03-24caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-008OTREXUP22.5MG/0.4ML (22.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2016-03-24caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-009OTREXUP PFS10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-010OTREXUP PFS15MG/0.6ML (15MG/0.6ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-011OTREXUP PFS17.5MG/0.7ML (17.5MG/0.7ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-012OTREXUP PFS20MG/0.8ML (20MG/0.8ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-013OTREXUP PFS22.5MG/0.9ML (22.5MG/0.9ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-014OTREXUP PFS25MG/ML (25MG/ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204824-001OTREXUP10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-002OTREXUP15MG/0.4ML (15MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-003OTREXUP20MG/0.4ML (20MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-004OTREXUP25MG/0.4ML (25MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-005OTREXUP7.5MG/0.4ML (7.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2014-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-006OTREXUP12.5MG/0.4ML (12.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2016-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-007OTREXUP17.5MG/0.4ML (17.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2016-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-008OTREXUP22.5MG/0.4ML (22.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2016-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-009OTREXUP PFS10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-010OTREXUP PFS15MG/0.6ML (15MG/0.6ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-011OTREXUP PFS17.5MG/0.7ML (17.5MG/0.7ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-012OTREXUP PFS20MG/0.8ML (20MG/0.8ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-013OTREXUP PFS22.5MG/0.9ML (22.5MG/0.9ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204824-014OTREXUP PFS25MG/ML (25MG/ML)SOLUTION / SUBCUTANEOUSRLD2017-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204824-001OTREXUP10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204824-002OTREXUP15MG/0.4ML (15MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204824-003OTREXUP20MG/0.4ML (20MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204824-004OTREXUP25MG/0.4ML (25MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2013-10-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204824-005OTREXUP7.5MG/0.4ML (7.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2014-11-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204824-006OTREXUP12.5MG/0.4ML (12.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2016-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204824-007OTREXUP17.5MG/0.4ML (17.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2016-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204824-008OTREXUP22.5MG/0.4ML (22.5MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2016-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204824-009OTREXUP PFS10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2017-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204824-010OTREXUP PFS15MG/0.6ML (15MG/0.6ML)SOLUTION / SUBCUTANEOUSRLD2017-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204824-011OTREXUP PFS17.5MG/0.7ML (17.5MG/0.7ML)SOLUTION / SUBCUTANEOUSRLD2017-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204824-012OTREXUP PFS20MG/0.8ML (20MG/0.8ML)SOLUTION / SUBCUTANEOUSRLD2017-05-3131067a03dcf5…

Observed Orange Book patent history#

Patent history page 1 of 109 · 4,352 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N204824-001114464412026-01-24Drug product2022-10-19caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00185625642026-01-24Drug product2013-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00195331022026-01-24Drug product2017-02-02caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00196299592026-01-24Drug product2017-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00180213352026-10-04Drug product2013-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-001107098442029-03-10Drug product2020-08-14caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-001116847232029-03-10Drug product2023-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00198679492029-03-10Drug product2020-08-14caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-001114977532030-03-19Drug product2022-12-13caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-001123576422030-03-19Drug product2025-08-15caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00184806312030-03-19U-1442Drug product2013-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00185798652030-03-19U-1442Drug product2013-11-21caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00189450632030-03-19U-1442Drug product2015-03-02caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00194213332030-03-19U-1442Drug product2016-09-21caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00188148342031-05-27Drug product2020-08-14caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-002114464412026-01-24Drug product2022-10-19caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00285625642026-01-24Drug product2013-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00295331022026-01-24Drug product2017-02-02caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00296299592026-01-24Drug product2017-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00280213352026-10-04Drug product2013-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-002107098442029-03-10Drug product2020-08-14caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-002116847232029-03-10Drug product2023-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00298679492029-03-10Drug product2020-08-14caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-002114977532030-03-19Drug product2022-12-13caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-002123576422030-03-19Drug product2025-08-15caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00284806312030-03-19U-1442Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00285798652030-03-19U-1442Drug product2013-11-21caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00289450632030-03-19U-1442Drug product2015-03-02caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00294213332030-03-19U-1442Drug product2016-09-21caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00288148342031-05-27Drug product2020-08-14caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-003114464412026-01-24Drug product2022-10-19caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00385625642026-01-24Drug product2013-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00395331022026-01-24Drug product2017-02-02caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00396299592026-01-24Drug product2017-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00380213352026-10-04Drug product2013-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-003107098442029-03-10Drug product2020-08-14caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-003116847232029-03-10Drug product2023-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-00398679492029-03-10Drug product2020-08-14caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-003114977532030-03-19Drug product2022-12-13caaa826d4ba7…
2026-08-18 06:07:402026-07N204824-003123576422030-03-19Drug product2025-08-15caaa826d4ba7…

Additional Listing Data#

Finished product
Yes
Brand name base
Otrexup

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOTREXATE20 mg/.4mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YL5FZ2Y5U1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 16 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1441402Internal RxNorm lookup
1441407Internal RxNorm lookup
1441411Internal RxNorm lookup
1441413Internal RxNorm lookup
1441416Internal RxNorm lookup
1441418Internal RxNorm lookup
1441422Internal RxNorm lookup
1441424Internal RxNorm lookup
1594757Internal RxNorm lookup
1594759Internal RxNorm lookup
1747179Internal RxNorm lookup
1747181Internal RxNorm lookup
1747185Internal RxNorm lookup
1747187Internal RxNorm lookup
1747192Internal RxNorm lookup
1747194Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9ab8ce16-f7de-41d4-a4c8-1c742621b6d5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2eb9a854-4fbc-9bbe-3199-41fc1018a1f0Product name920250224
3082de91-569a-4d57-b379-acbf37f1d5c3Product name120210312
f76135bc-a210-42d9-851b-1b73cbaccdb3Product name120200511
423544b2-e325-49ee-8910-4c5dfe41906fProduct name120181120
c9fd924b-0a8d-4d53-bf70-11070e24e4ddProduct name220181120
ce1e7cc6-4850-4cb1-8dde-8010b2fbc359Product name120181120
eb454f54-2806-4c31-a08b-8dcb08261099Product name220181120
d9cebc09-c68d-46f5-bdcd-fd82e945cc27Product name120170705
16ba0c1e-2371-48a4-8b4c-a9a338dfe1f3Product name220160504
88514aea-9d58-4ed2-b135-9811fb14c8fbProduct name120141209
0eba90a2-1cca-7e7b-28a5-85a09e2bc9a4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54436-020-01Otrexup1 in 1 CARTONINJECTION, SOLUTION115
54436-020-01Otrexup0.4 mL in 1 SYRINGEINJECTION, SOLUTION0.415
54436-020-02Otrexup0.4 mL in 1 SYRINGEINJECTION, SOLUTION0.415
54436-020-03Otrexup0.4 mL in 1 SYRINGEINJECTION, SOLUTION0.415
54436-020-03Otrexup1 in 1 CARTONINJECTION, SOLUTION115
54436-020-04Otrexup4 in 1 CARTONINJECTION, SOLUTION415

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54436-020-02ML - Milliliter54436-020614b54e8-fe92-4e4d-b650-1f273a1f34ad12014-01-04
54436-020-04ML - Milliliter54436-02062cc2dc3-7391-4ad6-9e26-252b1c5497c812014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHOTREXATEACTIVE INGREDIENTYL5FZ2Y5U1OTREXUP (METHOTREXATE) INJECTION, SOLUTION [ANTARES PHARMA, INC.]3
METHOTREXATEACTIVE MOIETYYL5FZ2Y5U1OTREXUP (METHOTREXATE) INJECTION, SOLUTION [ANTARES PHARMA, INC.]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOTREXUP (METHOTREXATE) INJECTION, SOLUTION [ANTARES PHARMA, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0ROTREXUP (METHOTREXATE) INJECTION, SOLUTION [ANTARES PHARMA, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54436-020OTREXUP (METHOTREXATE) INJECTION, SOLUTION [ANTARES PHARMA, INC.]15Current NDC, Legacy NDC, 6 package rows20250202_9ab8ce16-f7de-41d4-a4c8-1c742621b6d5.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
OtrexupMETHOTREXATEAntares Pharma, Inc.9ab8ce16-f7de-41d4-a4c8-1c742621b6d52025-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 204824
application number: NDA204824
ndc (product): 54436-020

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1441402methotrexate 10 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1747179methotrexate 12.5 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441411methotrexate 15 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1747185methotrexate 17.5 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441416methotrexate 20 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1747192methotrexate 22.5 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441422methotrexate 25 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1594757methotrexate 7.5 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441407Otrexup 10 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1747181Otrexup 12.5 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441413Otrexup 15 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1747187Otrexup 17.5 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441418Otrexup 20 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1747194Otrexup 22.5 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441424Otrexup 25 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1594759Otrexup 7.5 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
15947590.4 ML methotrexate 18.8 MG/ML Auto-Injector [Otrexup]SBD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
14414070.4 ML methotrexate 25 MG/ML Auto-Injector [Otrexup]SBD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
17471810.4 ML methotrexate 31.3 MG/ML Auto-Injector [Otrexup]SBD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
14414130.4 ML methotrexate 37.5 MG/ML Auto-Injector [Otrexup]SBD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
17471870.4 ML methotrexate 43.8 MG/ML Auto-Injector [Otrexup]SBD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
14414180.4 ML methotrexate 50 MG/ML Auto-Injector [Otrexup]SBD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
17471940.4 ML methotrexate 56.3 MG/ML Auto-Injector [Otrexup]SBD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
14414240.4 ML methotrexate 62.5 MG/ML Auto-Injector [Otrexup]SBD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
15947570.4 ML methotrexate 18.8 MG/ML Auto-InjectorSCD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
14414020.4 ML methotrexate 25 MG/ML Auto-InjectorSCD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
17471790.4 ML methotrexate 31.3 MG/ML Auto-InjectorSCD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
14414110.4 ML methotrexate 37.5 MG/ML Auto-InjectorSCD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
17471850.4 ML methotrexate 43.8 MG/ML Auto-InjectorSCD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
14414160.4 ML methotrexate 50 MG/ML Auto-InjectorSCD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
17471920.4 ML methotrexate 56.3 MG/ML Auto-InjectorSCD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
14414220.4 ML methotrexate 62.5 MG/ML Auto-InjectorSCD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
15947590.4 ML Otrexup 18.8 MG/ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
14414070.4 ML Otrexup 25 MG/ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
17471810.4 ML Otrexup 31.3 MG/ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
14414130.4 ML Otrexup 37.5 MG/ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
17471870.4 ML Otrexup 43.8 MG/ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
14414180.4 ML Otrexup 50 MG/ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
17471940.4 ML Otrexup 56.3 MG/ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
14414240.4 ML Otrexup 62.5 MG/ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441416methotrexate (as methotrexate sodium) 50 MG/ML 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441402methotrexate 10 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1747179methotrexate 12.5 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441411methotrexate 15 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1747185methotrexate 17.5 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441416methotrexate 20 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1747192methotrexate 22.5 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441422methotrexate 25 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1594757methotrexate 7.5 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441407Otrexup 10 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1747181Otrexup 12.5 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441413Otrexup 15 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1747187Otrexup 17.5 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441418Otrexup 20 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1747194Otrexup 22.5 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441424Otrexup 25 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441407Otrexup 25 MG/ML in 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441413Otrexup 37.5 MG/ML in 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441418Otrexup 50 MG/ML in 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441424Otrexup 62.5 MG/ML in 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1594759Otrexup 7.5 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54436-020-01544360020011 SYRINGE in 1 CARTON (54436-020-01) / .4 mL in 1 SYRINGE1 syringe2013-10-112027-04-30NoNoCurrent
54436-020-02544360020020.4 mL in 1 SYRINGE0.4 mlHistorical
54436-020-03544360020031 SYRINGE in 1 CARTON (54436-020-03) / .4 mL in 1 SYRINGE1 syringe2013-10-112027-04-30YesNoCurrent
54436-020-04544360020044 SYRINGE in 1 CARTON (54436-020-04) / .4 mL in 1 SYRINGE (54436-020-02) 4 syringe2013-10-112027-04-30NoNoCurrent