Zolmitriptan

Product NDC
65841-767
11-digit product format
658410767
Labeler code
65841
Product ID
65841-767_31419037-52ae-41bb-a03e-8965205ab347
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolmitriptan
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA202890
Marketing category
ANDA
Marketing start
2013-05-16
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

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
A202890-001ZOLMITRIPTANZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-15
A202890-002ZOLMITRIPTANZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALABRS2013-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202890-001AB
A202890-002AB

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 UTC2026-02A202890-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202890-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALABRS2013-05-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202890-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202890-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALABRS2013-05-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A202890-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202890-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALABRS2013-05-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202890-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202890-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALABRS2013-05-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202890-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202890-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALABRS2013-05-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202890-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202890-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALABRS2013-05-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202890-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202890-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALABRS2013-05-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202890-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202890-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALABRS2013-05-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202890-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202890-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALABRS2013-05-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202890-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A202890-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALABRS2013-05-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202890-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202890-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALABRS2013-05-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202890-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202890-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALABRS2013-05-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202890-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202890-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALABRS2013-05-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202890-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202890-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALABRS2013-05-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202890-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202890-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202890-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202890-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202890-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202890-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202890-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202890-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202890-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-15bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202890-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202890-001ZOLMITRIPTAN2.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-15782e0a99824c…
2021-12-28 21:50 UTC2021-12A202890-002ZOLMITRIPTAN5MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-05-15782e0a99824c…

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 UTC2026-02A202890-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202890-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202890-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202890-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202890-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202890-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202890-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202890-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202890-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202890-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202890-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202890-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202890-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202890-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202890-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202890-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202890-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202890-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202890-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202890-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202890-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202890-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202890-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202890-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202890-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202890-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202890-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202890-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202890-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202890-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202890-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202890-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202890-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202890-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202890-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202890-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202890-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202890-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202890-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202890-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Zolmitriptan
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
aae2d9cb-9938-4032-961f-f0afd1958b5dAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65841-767-01Zolmitriptan100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1006
65841-767-06Zolmitriptan30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING306
65841-767-10Zolmitriptan1000 in 1 BOTTLETABLET, ORALLY DISINTEGRATING10006
65841-767-16Zolmitriptan90 in 1 BOTTLETABLET, ORALLY DISINTEGRATING906
65841-767-30Zolmitriptan10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING106
65841-767-69Zolmitriptan6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING66
65841-767-77Zolmitriptan10 in 1 CARTONTABLET, ORALLY DISINTEGRATING106
65841-767-86Zolmitriptan1 in 1 CARTONTABLET, ORALLY DISINTEGRATING16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLMITRIPTANACTIVE INGREDIENT2FS66TH3YWZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
ZOLMITRIPTANACTIVE MOIETY2FS66TH3YWZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
GELATININACTIVE INGREDIENT2G86QN327LZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
ORANGEINACTIVE INGREDIENT5EVU04N5QUZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-767ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [ZYDUS LIFESCIENCES LIMITED]6Current NDC, Legacy NDC, 8 package rows20240817_aae2d9cb-9938-4032-961f-f0afd1958b5d.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
ZolmitriptanZOLMITRIPTANZydus Lifesciences Limitedaae2d9cb-9938-4032-961f-f0afd1958b5d2024-08-14Exact identifier
application applno (ANDA): 202890
application number: ANDA202890
ndc (product): 65841-767
ZolmitriptanZOLMITRIPTANZydus Pharmaceuticals USA Inc.7fc95729-2f5d-4d5c-b26c-3a13854f73e32023-11-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202890
application number: ANDA202890

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284201ZOLMitriptan 2.5 MG Disintegrating Oral TabletPSNaae2d9cb-9938-4032-961f-f0afd1958b5d6
351134ZOLMitriptan 5 MG Disintegrating Oral TabletPSNaae2d9cb-9938-4032-961f-f0afd1958b5d6
284201zolmitriptan 2.5 MG Disintegrating Oral TabletSCDaae2d9cb-9938-4032-961f-f0afd1958b5d6
351134zolmitriptan 5 MG Disintegrating Oral TabletSCDaae2d9cb-9938-4032-961f-f0afd1958b5d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-767-0165841076701100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-767-01) 2013-05-160000-00-00NoNoCurrent
65841-767-066584107670630 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-767-06) 2013-05-160000-00-00NoNoCurrent
65841-767-10658410767101000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-767-10) 2013-05-160000-00-00NoNoCurrent
65841-767-166584107671690 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-767-16) 2013-05-160000-00-00NoNoCurrent
65841-767-306584107673010 in 1 BLISTER PACKHistorical
65841-767-69658410767696 in 1 BLISTER PACKHistorical
65841-767-776584107677710 BLISTER PACK in 1 CARTON (65841-767-77) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65841-767-30) 10 blister pack2013-05-160000-00-00NoNoCurrent
65841-767-86658410767861 BLISTER PACK in 1 CARTON (65841-767-86) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65841-767-69) 1 blister pack2013-05-160000-00-00NoNoCurrent