Home NDC 36000-289 Sumatriptan
Product NDC 36000-289
11-digit product format 360000289
Labeler code 36000
Product ID 36000-289_62c6c207-3e07-498e-ac5c-2f6e1a632a7e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sumatriptan
Dosage form INJECTION
Route SUBCUTANEOUS
Labeler Baxter Healthcare Corporation
Application ANDA207101
Marketing category ANDA
Marketing start 2023-01-19
Substance SUMATRIPTAN SUCCINATE
Active strength 6 mg/.5mL
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 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 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 36000-289-25 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 36000-289-05 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 36000-289-10 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 36000-289-25 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 36000-289-05 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 36000-289-10 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207101-001 SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS 2023-01-19
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.
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 2026-08-18 06:07:40 2026-07 A207101-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS 2023-01-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207101-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS 2023-01-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207101-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS 2023-01-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207101-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS 2023-01-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207101-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS 2023-01-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207101-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS 2023-01-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207101-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS 2023-01-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207101-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS 2023-01-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207101-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS 2023-01-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207101-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS 2023-01-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207101-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS 2023-01-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207101-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS 2023-01-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207101-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS 2023-01-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207101-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS 2023-01-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207101-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS 2023-01-19 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207101-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS 2023-01-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207101-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS 2023-01-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207101-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS 2023-01-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207101-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS 2023-01-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207101-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS 2023-01-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207101-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP 2023-01-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207101-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP 2023-01-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207101-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP 2023-01-19 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207101-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS 2023-01-19 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207101-001 AP 1 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207101-001 AP 1 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207101-001 AP 1 053a50430f4f…
Additional Listing Data#
Finished product Yes
Brand name base Sumatriptan
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SUMATRIPTAN SUCCINATE 6 mg/.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination J8BDZ68989 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313165 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 36000-289-05 Sumatriptan 0.5 mL in 1 VIAL INJECTION 0.5 5 36000-289-05 Sumatriptan 5 in 1 CARTON INJECTION 5 5 36000-289-10 Sumatriptan 10 in 1 CARTON INJECTION 10 5 36000-289-10 Sumatriptan 0.5 mL in 1 VIAL INJECTION 0.5 5 36000-289-25 Sumatriptan 0.5 mL in 1 VIAL INJECTION 0.5 5 36000-289-25 Sumatriptan 25 in 1 CARTON INJECTION 25 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36000-289 SUMATRIPTAN INJECTION [BAXTER HEALTHCARE CORPORATION] 3 Current NDC, 6 package rows 20241101_d13df081-648c-44c0-9854-5a1bfe23ae89.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 Sample Exclude flag Status 36000-289-05 36000028905 5 VIAL in 1 CARTON (36000-289-05) / .5 mL in 1 VIAL 5 vial 2023-01-19 No No Current 36000-289-10 36000028910 10 VIAL in 1 CARTON (36000-289-10) / .5 mL in 1 VIAL 10 vial 2023-01-19 No No Current 36000-289-25 36000028925 25 VIAL in 1 CARTON (36000-289-25) / .5 mL in 1 VIAL 25 vial 2023-01-19 No No Current