Home NDC 87063-287 naratriptan
Product NDC 87063-287
11-digit product format 870630287
Labeler code 87063
Product ID 87063-287_586e484f-099e-4e71-e063-6294a90af7d1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name naratriptan
Dosage form TABLET
Route ORAL
Labeler ASCLEMED USA INC.
Application ANDA200502
Marketing category ANDA
Marketing start 2011-03-15
Substance NARATRIPTAN HYDROCHLORIDE
Active strength 1 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 43 .
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 A200502-001 NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2011-02-28 A200502-002 NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB RS 2011-02-28
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 · 86 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 2026-09-14 22:38:34 2026-08 A200502-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2011-02-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200502-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB RS 2011-02-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200502-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2011-02-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200502-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB RS 2011-02-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200502-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2011-02-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200502-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB RS 2011-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200502-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2011-02-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200502-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB RS 2011-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200502-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2011-02-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200502-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB RS 2011-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200502-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2011-02-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200502-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB RS 2011-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200502-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2011-02-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200502-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB RS 2011-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200502-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2011-02-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200502-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB RS 2011-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200502-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2011-02-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200502-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB RS 2011-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200502-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2011-02-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200502-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB RS 2011-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200502-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2011-02-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200502-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB RS 2011-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200502-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2011-02-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200502-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB RS 2011-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200502-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2011-02-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200502-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB RS 2011-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200502-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2011-02-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200502-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB RS 2011-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200502-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2011-02-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200502-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB RS 2011-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200502-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2011-02-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A200502-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB RS 2011-02-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200502-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2011-02-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200502-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2011-02-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200502-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2011-02-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A200502-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2011-02-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200502-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2011-02-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A200502-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2011-02-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200502-001 NARATRIPTAN EQ 1MG BASE TABLET / ORAL AB 2011-02-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A200502-002 NARATRIPTAN EQ 2.5MG BASE TABLET / ORAL AB 2011-02-28 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base naratriptan
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NARATRIPTAN HYDROCHLORIDE 1 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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87063-287-09 87063028709 9 TABLET in 1 BLISTER PACK (87063-287-09) 9 tablet 2026-08-07 No No Current 87063-287-12 87063028712 12 TABLET in 1 BOTTLE (87063-287-12) 12 tablet 2026-08-07 No No Current 87063-287-30 87063028730 30 TABLET in 1 BOTTLE (87063-287-30) 30 tablet 2026-08-07 No No Current 87063-287-60 87063028760 60 TABLET in 1 BOTTLE (87063-287-60) 60 tablet 2026-08-07 No No Current 87063-287-90 87063028790 90 TABLET in 1 BOTTLE (87063-287-90) 90 tablet 2026-08-07 No No Current