Naratriptan

Product NDC
50090-6162
Requested package NDC
50090-6162-0
11-digit product format
500906162
Labeler code
50090
Product ID
50090-6162_4f5b1665-0046-4dad-9d14-e2fe9c8b1c81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naratriptan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091441
Marketing category
ANDA
Marketing start
2022-04-11
Marketing end
0000-00-00
Substance
NARATRIPTAN HYDROCHLORIDE
Active strength
3 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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-616250090-6162-0DDiscontinued by firm2026-08-03

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

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
A091441-001NARATRIPTANNARATRIPTAN HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2012-04-30
A091441-002NARATRIPTANNARATRIPTAN HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2012-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091441-001AB
A091441-002AB

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 UTC2026-02A091441-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2012-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091441-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2012-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091441-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2012-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091441-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2012-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A091441-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2012-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091441-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2012-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091441-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2012-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091441-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2012-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091441-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2012-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091441-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2012-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091441-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2012-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091441-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2012-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091441-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2012-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091441-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2012-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091441-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2012-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091441-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2012-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091441-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2012-04-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091441-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2012-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091441-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2012-04-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A091441-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2012-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091441-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2012-04-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091441-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2012-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091441-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2012-04-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091441-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2012-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091441-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2012-04-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091441-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2012-04-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091441-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2012-04-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091441-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2012-04-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091441-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2012-04-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091441-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2012-04-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091441-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2012-04-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091441-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2012-04-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091441-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2012-04-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091441-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2012-04-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091441-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2012-04-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091441-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2012-04-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091441-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2012-04-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091441-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2012-04-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091441-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2012-04-30782e0a99824c…
2021-12-28 21:50 UTC2021-12A091441-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2012-04-30782e0a99824c…

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 UTC2026-02A091441-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091441-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091441-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091441-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091441-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091441-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091441-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091441-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091441-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091441-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091441-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091441-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091441-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091441-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091441-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091441-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091441-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091441-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091441-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091441-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091441-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091441-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091441-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091441-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091441-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091441-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091441-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091441-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091441-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091441-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091441-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091441-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091441-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091441-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091441-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091441-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091441-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091441-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091441-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091441-002AB1782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6162-0EA - Each50090-61626410c9a6-b80c-4655-9322-d7690a2cb3a712022-12-07

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
NaratriptanNARATRIPTANBionpharma Inc.93b7e6c2-e6a7-4f6b-9ecd-62d6bb0a6dda2026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091441
application number: ANDA091441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6162-0500906162001 BLISTER PACK in 1 CARTON (50090-6162-0) > 9 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2022-10-110000-00-00NoNoCurrent