naratriptan

Product NDC
23155-055
11-digit product format
231550055
Labeler code
23155
Product ID
23155-055_61e37b1d-f036-4c35-9073-ce456efd8007
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naratriptan
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA200502
Marketing category
ANDA
Marketing start
2011-03-15
Substance
NARATRIPTAN HYDROCHLORIDE
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
A200502-001NARATRIPTANNARATRIPTAN HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2011-02-28
A200502-002NARATRIPTANNARATRIPTAN HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALABRS2011-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200502-001AB
A200502-002AB

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 UTC2026-02A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2011-02-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2011-02-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2011-02-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2011-02-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2011-02-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2011-02-28782e0a99824c…

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 UTC2026-02A200502-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200502-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200502-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200502-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200502-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200502-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200502-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200502-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200502-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200502-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200502-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200502-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200502-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200502-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200502-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200502-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200502-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200502-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200502-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200502-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200502-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200502-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200502-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200502-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200502-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200502-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200502-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200502-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200502-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200502-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200502-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200502-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200502-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200502-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200502-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200502-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200502-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200502-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200502-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A200502-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NARATRIPTAN HYDROCHLORIDE2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
10X8X4P12ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311918Internal RxNorm lookup
314135Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
41c29652-32f8-48dc-9038-0e2195aa2084Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4672872e-6e11-64c5-0823-02c8882da049Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-055-03naratriptan30 in 1 BOTTLETABLET3020
23155-055-05naratriptan500 in 1 BOTTLETABLET50020
23155-055-19naratriptan9 in 1 BLISTER PACKTABLET920

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-055-19EA - Each23155-0551be45f32-1f17-48fc-9175-c1e89f7a79c012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NARATRIPTAN HYDROCHLORIDEACTIVE INGREDIENT10X8X4P12ZNARATRIPTAN TABLET [HERITAGE PHARMACEUTICALS INC.]8
NARATRIPTANACTIVE MOIETYQX3KXL1ZA2NARATRIPTAN TABLET [HERITAGE PHARMACEUTICALS INC.]8
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKNARATRIPTAN TABLET [HERITAGE PHARMACEUTICALS INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNARATRIPTAN TABLET [HERITAGE PHARMACEUTICALS INC.]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NARATRIPTAN TABLET [HERITAGE PHARMACEUTICALS INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNARATRIPTAN TABLET [HERITAGE PHARMACEUTICALS INC.]8
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4NARATRIPTAN TABLET [HERITAGE PHARMACEUTICALS INC.]8
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6NARATRIPTAN TABLET [HERITAGE PHARMACEUTICALS INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NARATRIPTAN TABLET [HERITAGE PHARMACEUTICALS INC.]8
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNARATRIPTAN TABLET [HERITAGE PHARMACEUTICALS INC.]8
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BNARATRIPTAN TABLET [HERITAGE PHARMACEUTICALS INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1UNARATRIPTAN TABLET [HERITAGE PHARMACEUTICALS INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNARATRIPTAN TABLET [HERITAGE PHARMACEUTICALS INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-055NARATRIPTAN TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]19Current NDC, Legacy NDC, 3 package rows20230826_41c29652-32f8-48dc-9038-0e2195aa2084.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
naratriptanNARATRIPTANHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.41c29652-32f8-48dc-9038-0e2195aa20842025-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200502
application number: ANDA200502
ndc (product): 23155-055

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311918naratriptan 1 MG Oral TabletPSN41c29652-32f8-48dc-9038-0e2195aa208420
314135naratriptan 2.5 MG Oral TabletPSN41c29652-32f8-48dc-9038-0e2195aa208420
311918naratriptan 1 MG Oral TabletSCD41c29652-32f8-48dc-9038-0e2195aa208420
314135naratriptan 2.5 MG Oral TabletSCD41c29652-32f8-48dc-9038-0e2195aa208420
311918naratriptan (as naratriptan hydrochloride) 1 MG Oral TabletSY41c29652-32f8-48dc-9038-0e2195aa208420
314135naratriptan (as naratriptan hydrochloride) 2.5 MG Oral TabletSY41c29652-32f8-48dc-9038-0e2195aa208420

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-055-032315500550330 TABLET in 1 BOTTLE (23155-055-03) 30 tablet2011-03-150000-00-00NoNoCurrent
23155-055-0523155005505500 TABLET in 1 BOTTLE (23155-055-05) 500 tablet2011-03-150000-00-00NoNoCurrent
23155-055-19231550055199 TABLET in 1 BLISTER PACK (23155-055-19) 9 tablet2011-03-150000-00-00NoNoCurrent