Zolmitriptan OD

Product NDC
59746-461
Requested package NDC
59746-461-16
11-digit product format
597460461
Labeler code
59746
Product ID
59746-461_5d9c2d59-8564-44d8-bd79-0e0b34ec50bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolmitriptan
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Jubilant Cadista Pharmacuticals Inc.
Application
ANDA202956
Marketing category
ANDA
Marketing start
2015-09-17
Substance
ZOLMITRIPTAN
Active strength
2.5 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
2026-12-31
Current FDA listing
Yes

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 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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

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
A202956-001ZOLMITRIPTANZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-17
A202956-002ZOLMITRIPTANZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202956-001AB
A202956-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202956-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202956-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202956-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202956-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202956-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202956-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202956-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202956-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202956-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202956-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202956-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202956-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202956-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202956-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202956-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202956-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202956-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202956-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202956-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A202956-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202956-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202956-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202956-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202956-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202956-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202956-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202956-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202956-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202956-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202956-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202956-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202956-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202956-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202956-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202956-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202956-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202956-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-17bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202956-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202956-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-17782e0a99824c…
2021-12-28 21:50 UTC2021-12A202956-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-09-17782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202956-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202956-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202956-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202956-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202956-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202956-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202956-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202956-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202956-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202956-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202956-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202956-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202956-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202956-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202956-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202956-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202956-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202956-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202956-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202956-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202956-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202956-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202956-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202956-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202956-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202956-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202956-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202956-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202956-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202956-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202956-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202956-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202956-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202956-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202956-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202956-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202956-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202956-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202956-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202956-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Zolmitriptan OD
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLMITRIPTAN2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2FS66TH3YWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
284201Internal RxNorm lookup
351134Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a6a32fc6-4243-9cdd-91c7-b8a58e0f9811Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a0fbe307-6e31-a71d-5232-3216747b9b34Product name220220316
49286735-675f-7ca8-3815-48cfc7bb5a5aProduct name920180828

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59746-461-16Zolmitriptan OD2 in 1 CARTONTABLET, ORALLY DISINTEGRATING27
59746-461-16Zolmitriptan OD3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-461-16EA - Each59746-46101cc7916-7660-44f3-8f8a-edf9f76ce19612017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZolmitriptanACTIVE INGREDIENT2FS66TH3YWZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
ZolmitriptanACTIVE MOIETY2FS66TH3YWZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Acesulfame PotassiumINACTIVE INGREDIENT23OV73Q5G9ZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
CrospovidoneINACTIVE INGREDIENT68401960MKZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Dimethylaminoethyl Methacrylate - Butyl Methacrylate - Methyl Methacrylate CopolymerINACTIVE INGREDIENT905HNO1SIHZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Hydroxypropyl Cellulose (type H)INACTIVE INGREDIENTRFW2ET671PZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Magnesium Aluminometasilicate Type I-aINACTIVE INGREDIENT7LVU907546ZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Magnesium Aluminum Silicate Type IaINACTIVE INGREDIENTSUS08ZOA9SZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Magnesium StearateINACTIVE INGREDIENT70097M6I30ZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
MannitolINACTIVE INGREDIENT3OWL53L36AZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
PeppermintINACTIVE INGREDIENTV95R5KMY2BZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4ZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
TalcINACTIVE INGREDIENT7SEV7J4R1UZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-461ZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20241220_a6a32fc6-4243-9cdd-91c7-b8a58e0f9811.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zolmitriptan ODZOLMITRIPTANJubilant Cadista Pharmacuticals Inc.a6a32fc6-4243-9cdd-91c7-b8a58e0f98112025-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202956
application number: ANDA202956
ndc (package): 59746-461-16
ndc (product): 59746-461
ndc11 (package): 59746046116
Zolmitriptan ODZOLMITRIPTANAvKARE3f0040a6-b1d6-3d73-e063-6294a90af23c2025-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202956
application number: ANDA202956

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284201ZOLMitriptan 2.5 MG Disintegrating Oral TabletPSNa6a32fc6-4243-9cdd-91c7-b8a58e0f98117
351134ZOLMitriptan 5 MG Disintegrating Oral TabletPSNa6a32fc6-4243-9cdd-91c7-b8a58e0f98117
284201zolmitriptan 2.5 MG Disintegrating Oral TabletSCDa6a32fc6-4243-9cdd-91c7-b8a58e0f98117
351134zolmitriptan 5 MG Disintegrating Oral TabletSCDa6a32fc6-4243-9cdd-91c7-b8a58e0f98117

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-461-16597460461162 BLISTER PACK in 1 CARTON (59746-461-16) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK2 blister pack2015-09-170000-00-00NoNoCurrent