Home NDC 42043-131 Naratriptan
Product NDC 42043-131
11-digit product format 420430131
Labeler code 42043
Product ID 42043-131_bed06fde-8a58-433d-aaef-5b9e5e58722c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naratriptan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler OrchidPharma, Inc
Application ANDA091441
Marketing category ANDA
Marketing start 2012-12-12
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 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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42043-131-09 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42043-131-09 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42043-131-09 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42043-131-09 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42043-131-09 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42043-131-09 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42043-131-09 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42043-131-09 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42043-131-09 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 42043-131-09 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 42043-131-09 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 42043-131-09 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 42043-131-09 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 42043-131-09 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 42043-131-09 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
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 A091441-001 NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2012-04-30 A091441-002 NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2012-04-30
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 A091441-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2012-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091441-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2012-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091441-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2012-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091441-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2012-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091441-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2012-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091441-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2012-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091441-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2012-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091441-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2012-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091441-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2012-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091441-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2012-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091441-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2012-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091441-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2012-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091441-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2012-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091441-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2012-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091441-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2012-04-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091441-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2012-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091441-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2012-04-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091441-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2012-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091441-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2012-04-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091441-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2012-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091441-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2012-04-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091441-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2012-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091441-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2012-04-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091441-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2012-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091441-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2012-04-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091441-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2012-04-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091441-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2012-04-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091441-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2012-04-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091441-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2012-04-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091441-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2012-04-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091441-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2012-04-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091441-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2012-04-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091441-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2012-04-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091441-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2012-04-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091441-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2012-04-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091441-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2012-04-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091441-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2012-04-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A091441-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2012-04-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091441-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2012-04-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A091441-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2012-04-30 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NARATRIPTAN HYDROCHLORIDE ACTIVE INGREDIENT 10X8X4P12Z NARATRIPTAN TABLET, FILM COATED [ORCHIDPHARMA INC] 7 NARATRIPTAN ACTIVE MOIETY QX3KXL1ZA2 NARATRIPTAN TABLET, FILM COATED [ORCHIDPHARMA INC] 7 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK NARATRIPTAN TABLET, FILM COATED [ORCHIDPHARMA INC] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NARATRIPTAN TABLET, FILM COATED [ORCHIDPHARMA INC] 7 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NARATRIPTAN TABLET, FILM COATED [ORCHIDPHARMA INC] 7 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK NARATRIPTAN TABLET, FILM COATED [ORCHIDPHARMA INC] 7 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT NARATRIPTAN TABLET, FILM COATED [ORCHIDPHARMA INC] 7 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 NARATRIPTAN TABLET, FILM COATED [ORCHIDPHARMA INC] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NARATRIPTAN TABLET, FILM COATED [ORCHIDPHARMA INC] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NARATRIPTAN TABLET, FILM COATED [ORCHIDPHARMA INC] 7 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 NARATRIPTAN TABLET, FILM COATED [ORCHIDPHARMA INC] 7
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42043-131-09 42043013109 1 BLISTER PACK in 1 CARTON (42043-131-09) > 9 TABLET, FILM COATED in 1 BLISTER PACK (42043-131-00) 1 blister pack 2012-12-12 0000-00-00 No No Current