Zolmitriptan

Product NDC
68001-249
11-digit product format
680010249
Labeler code
68001
Product ID
68001-249_4f68e4d5-c239-eb2d-e063-6294a90af478
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolmitriptan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA201779
Marketing category
ANDA
Marketing start
2014-03-13
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
2027-12-31
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
A201779-001ZOLMITRIPTANZOLMITRIPTAN2.5MGTABLET / ORALAB2013-05-14
A201779-002ZOLMITRIPTANZOLMITRIPTAN5MGTABLET / ORALAB2013-05-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201779-001AB
A201779-002AB

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 UTC2026-02A201779-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2013-05-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201779-002ZOLMITRIPTAN5MGTABLET / ORALAB2013-05-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201779-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2013-05-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201779-002ZOLMITRIPTAN5MGTABLET / ORALAB2013-05-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A201779-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2013-05-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201779-002ZOLMITRIPTAN5MGTABLET / ORALAB2013-05-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201779-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2013-05-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201779-002ZOLMITRIPTAN5MGTABLET / ORALAB2013-05-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201779-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2013-05-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201779-002ZOLMITRIPTAN5MGTABLET / ORALAB2013-05-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201779-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2013-05-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201779-002ZOLMITRIPTAN5MGTABLET / ORALAB2013-05-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201779-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2013-05-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201779-002ZOLMITRIPTAN5MGTABLET / ORALAB2013-05-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201779-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2013-05-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201779-002ZOLMITRIPTAN5MGTABLET / ORALAB2013-05-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201779-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2013-05-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201779-002ZOLMITRIPTAN5MGTABLET / ORALAB2013-05-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201779-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2013-05-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A201779-002ZOLMITRIPTAN5MGTABLET / ORALAB2013-05-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201779-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2013-05-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201779-002ZOLMITRIPTAN5MGTABLET / ORALAB2013-05-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201779-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2013-05-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201779-002ZOLMITRIPTAN5MGTABLET / ORALAB2013-05-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201779-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2013-05-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201779-002ZOLMITRIPTAN5MGTABLET / ORALAB2013-05-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201779-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2013-05-148072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201779-002ZOLMITRIPTAN5MGTABLET / ORALAB2013-05-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201779-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2013-05-145c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201779-002ZOLMITRIPTAN5MGTABLET / ORALAB2013-05-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201779-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2013-05-145d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201779-002ZOLMITRIPTAN5MGTABLET / ORALAB2013-05-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201779-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2013-05-144b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201779-002ZOLMITRIPTAN5MGTABLET / ORALAB2013-05-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201779-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2013-05-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201779-002ZOLMITRIPTAN5MGTABLET / ORALAB2013-05-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201779-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2013-05-14bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201779-002ZOLMITRIPTAN5MGTABLET / ORALAB2013-05-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201779-001ZOLMITRIPTAN2.5MGTABLET / ORALAB2013-05-14782e0a99824c…
2021-12-28 21:50 UTC2021-12A201779-002ZOLMITRIPTAN5MGTABLET / ORALAB2013-05-14782e0a99824c…

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 UTC2026-02A201779-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201779-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201779-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201779-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201779-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201779-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201779-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201779-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201779-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201779-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201779-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201779-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201779-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201779-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201779-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201779-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201779-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201779-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201779-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201779-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201779-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201779-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201779-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201779-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201779-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201779-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201779-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201779-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201779-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201779-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201779-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201779-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201779-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201779-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201779-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201779-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201779-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201779-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201779-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A201779-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Zolmitriptan
Listing expiration
2027-12-31

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
200193Internal RxNorm lookup
200194Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e6628b7a-0b63-4e6f-a5e7-2fa195265235Available 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
68001-249-01Zolmitriptan1 in 1 CARTONTABLET, FILM COATED17
68001-249-19Zolmitriptan6 in 1 BLISTER PACKTABLET, FILM COATED67

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-249-01EA - Each68001-2490bb84493-6e3e-415d-8a40-4f28e856999d12014-05-02
68001-249-19EA - Each68001-24904202ecd-5ea3-4a38-9af8-c81c6d4ac3f012014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLMITRIPTANACTIVE INGREDIENT2FS66TH3YWZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
ZOLMITRIPTANACTIVE MOIETY2FS66TH3YWZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-249ZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]6Current NDC, Legacy NDC, 2 package rows20200110_e6628b7a-0b63-4e6f-a5e7-2fa195265235.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
ZolmitriptanZOLMITRIPTANBluePoint Laboratoriese6628b7a-0b63-4e6f-a5e7-2fa1952652352026-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201779
application number: ANDA201779
ndc (product): 68001-249
ZolmitriptanZOLMITRIPTANGlenmark Pharmaceuticals Inc.,USA333caafc-2e63-49f8-a0c6-534e528d228d2026-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201779
application number: ANDA201779

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200193ZOLMitriptan 2.5 MG Oral TabletPSNe6628b7a-0b63-4e6f-a5e7-2fa1952652357
200194ZOLMitriptan 5 MG Oral TabletPSNe6628b7a-0b63-4e6f-a5e7-2fa1952652357
200193zolmitriptan 2.5 MG Oral TabletSCDe6628b7a-0b63-4e6f-a5e7-2fa1952652357
200194zolmitriptan 5 MG Oral TabletSCDe6628b7a-0b63-4e6f-a5e7-2fa1952652357

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-249-01680010249011 BLISTER PACK in 1 CARTON (68001-249-01) / 6 TABLET, FILM COATED in 1 BLISTER PACK (68001-249-19) 1 blister pack2014-03-130000-00-00NoNoCurrent
68001-249-19680010249196 in 1 BLISTER PACKHistorical