Home NDC 0054-0279 Naratriptan
Product NDC 0054-0279
11-digit product format 000540279
Labeler code 0054
Product ID 0054-0279_14eeba7d-700d-4ac1-a71e-d6a1fca8aaab
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naratriptan
Dosage form TABLET
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA090381
Marketing category ANDA
Marketing start 2010-07-07
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090381-001 NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2010-07-07 A090381-002 NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090381-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2010-07-07 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A090381-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2010-07-07 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Naratriptan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NARATRIPTAN HYDROCHLORIDE 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 10X8X4P12Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311918 Internal RxNorm lookup 314135 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0054-0279-03 Naratriptan 9 in 1 BOTTLE TABLET 9 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NARATRIPTAN HYDROCHLORIDE ACTIVE INGREDIENT 10X8X4P12Z NARATRIPTAN TABLET [ROXANE LABORATORIES, INC.] 3 NARATRIPTAN ACTIVE MOIETY QX3KXL1ZA2 NARATRIPTAN TABLET [ROXANE LABORATORIES, INC.] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK NARATRIPTAN TABLET [ROXANE LABORATORIES, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NARATRIPTAN TABLET [ROXANE LABORATORIES, INC.] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NARATRIPTAN TABLET [ROXANE LABORATORIES, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NARATRIPTAN TABLET [ROXANE LABORATORIES, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NARATRIPTAN TABLET [ROXANE LABORATORIES, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0279 NARATRIPTAN TABLET [HIKMA PHARMACEUTICALS USA INC.] 7 Current NDC, Legacy NDC, 1 package rows 20230725_fd1944b3-8054-4faa-a82e-d818dfdd3875.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0054-0279-03 00054027903 9 TABLET in 1 BOTTLE (0054-0279-03) 9 tablet 2010-10-07 0000-00-00 No No Current