Zolmitriptan

Product NDC
50742-626
11-digit product format
507420626
Labeler code
50742
Product ID
50742-626_524fe00b-e641-49c1-a9a8-08f398290bfa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolmitriptan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA206973
Marketing category
ANDA
Marketing start
2017-09-15
Marketing end
0000-00-00
Substance
ZOLMITRIPTAN
Active strength
5 mg/1
Pharmacologic classes
Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50742-626DDiscontinued by firm2026-08-17
excluded packagepackage50742-62650742-626-03DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50742-626-03DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50742-626-03DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50742-626-03DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50742-626-03DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50742-626-03DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50742-626-03DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50742-626-03DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50742-626-03DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50742-626-03DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50742-626-03IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50742-626-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50742-626-03IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50742-626-03IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50742-626-03IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50742-626-03IInactivated by FDA1332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206973-001ZOLMITRIPTANZOLMITRIPTAN2.5MGTABLET / ORALAB2017-06-30
A206973-002ZOLMITRIPTANZOLMITRIPTAN5MGTABLET / ORALAB2017-06-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A206973-001AB
A206973-002AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A206973-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2017-06-30caaa826d4ba7…
2026-08-18 06:07:402026-07A206973-002ZOLMITRIPTAN5MGTABLET / ORALAB2017-06-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206973-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2017-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206973-002ZOLMITRIPTAN5MGTABLET / ORALAB2017-06-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206973-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2017-06-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206973-002ZOLMITRIPTAN5MGTABLET / ORALAB2017-06-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A206973-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2017-06-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206973-002ZOLMITRIPTAN5MGTABLET / ORALAB2017-06-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206973-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2017-06-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206973-002ZOLMITRIPTAN5MGTABLET / ORALAB2017-06-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206973-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2017-06-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206973-002ZOLMITRIPTAN5MGTABLET / ORALAB2017-06-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206973-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2017-06-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206973-002ZOLMITRIPTAN5MGTABLET / ORALAB2017-06-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206973-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2017-06-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206973-002ZOLMITRIPTAN5MGTABLET / ORALAB2017-06-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206973-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2017-06-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206973-002ZOLMITRIPTAN5MGTABLET / ORALAB2017-06-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206973-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2017-06-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206973-002ZOLMITRIPTAN5MGTABLET / ORALAB2017-06-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206973-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2017-06-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A206973-002ZOLMITRIPTAN5MGTABLET / ORALAB2017-06-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206973-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2017-06-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206973-002ZOLMITRIPTAN5MGTABLET / ORALAB2017-06-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206973-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2017-06-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206973-002ZOLMITRIPTAN5MGTABLET / ORALAB2017-06-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206973-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2017-06-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206973-002ZOLMITRIPTAN5MGTABLET / ORALAB2017-06-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206973-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2017-06-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206973-002ZOLMITRIPTAN5MGTABLET / ORALAB2017-06-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206973-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2017-06-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206973-002ZOLMITRIPTAN5MGTABLET / ORALAB2017-06-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206973-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2017-06-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206973-002ZOLMITRIPTAN5MGTABLET / ORALAB2017-06-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206973-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2017-06-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206973-002ZOLMITRIPTAN5MGTABLET / ORALAB2017-06-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206973-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2017-06-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206973-002ZOLMITRIPTAN5MGTABLET / ORALAB2017-06-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206973-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2017-06-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206973-002ZOLMITRIPTAN5MGTABLET / ORALAB2017-06-30bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A206973-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206973-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206973-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206973-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206973-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206973-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206973-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206973-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206973-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206973-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206973-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206973-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206973-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206973-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206973-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206973-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206973-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206973-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206973-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206973-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206973-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206973-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206973-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206973-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206973-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206973-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206973-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206973-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206973-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206973-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206973-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206973-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206973-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206973-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206973-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206973-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206973-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206973-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206973-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206973-002AB1bb7c543d1eb4…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-626-03EA - Each50742-626371c20ce-ebae-4be2-9cf8-2c1efd4d434412019-01-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50742-626-03507420626031 BLISTER PACK in 1 CARTON (50742-626-03) > 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2017-09-150000-00-00NoNoCurrent