Zolmitriptan

Product NDC
68382-715
11-digit product format
683820715
Labeler code
68382
Product ID
68382-715_c8bbe1ff-34e4-4638-ac8a-00b1ceb2f310
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolmitriptan
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
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
7fc95729-2f5d-4d5c-b26c-3a13854f73e3Available 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
68382-715-01Zolmitriptan100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1008
68382-715-06Zolmitriptan30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING308
68382-715-10Zolmitriptan1000 in 1 BOTTLETABLET, ORALLY DISINTEGRATING10008
68382-715-16Zolmitriptan90 in 1 BOTTLETABLET, ORALLY DISINTEGRATING908
68382-715-30Zolmitriptan10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING108
68382-715-69Zolmitriptan6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING68
68382-715-77Zolmitriptan10 in 1 CARTONTABLET, ORALLY DISINTEGRATING108
68382-715-86Zolmitriptan1 in 1 CARTONTABLET, ORALLY DISINTEGRATING18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-715-69EA - Each68382-715e1f8c5bb-1ca2-43d7-8ea7-939f3ae62f2812013-06-04
68382-715-86EA - Each68382-715414ce252-cb94-4f7c-bd5b-f306f25224f412013-06-04

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-715ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [ZYDUS PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 8 package rows20231110_7fc95729-2f5d-4d5c-b26c-3a13854f73e3.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
ZolmitriptanZOLMITRIPTANZydus Pharmaceuticals USA Inc.7fc95729-2f5d-4d5c-b26c-3a13854f73e32023-11-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202890
application number: ANDA202890
ndc (product): 68382-715

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284201ZOLMitriptan 2.5 MG Disintegrating Oral TabletPSN7fc95729-2f5d-4d5c-b26c-3a13854f73e38
351134ZOLMitriptan 5 MG Disintegrating Oral TabletPSN7fc95729-2f5d-4d5c-b26c-3a13854f73e38
284201zolmitriptan 2.5 MG Disintegrating Oral TabletSCD7fc95729-2f5d-4d5c-b26c-3a13854f73e38
351134zolmitriptan 5 MG Disintegrating Oral TabletSCD7fc95729-2f5d-4d5c-b26c-3a13854f73e38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-715-0168382071501100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-715-01) 2013-05-160000-00-00NoNoCurrent
68382-715-066838207150630 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-715-06) 2013-05-160000-00-00NoNoCurrent
68382-715-10683820715101000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-715-10) 2013-05-160000-00-00NoNoCurrent
68382-715-166838207151690 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-715-16) 2013-05-160000-00-00NoNoCurrent
68382-715-306838207153010 in 1 BLISTER PACKHistorical
68382-715-69683820715696 in 1 BLISTER PACKHistorical
68382-715-776838207157710 BLISTER PACK in 1 CARTON (68382-715-77) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-715-30) 10 blister pack2013-05-160000-00-00NoNoCurrent
68382-715-86683820715861 BLISTER PACK in 1 CARTON (68382-715-86) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-715-69) 1 blister pack2013-05-160000-00-00NoNoCurrent