Home NDC 46708-656 SUMATRIPTAN SUCCINATE
Product NDC 46708-656
11-digit product format 467080656
Labeler code 46708
Product ID 46708-656_16b7e44d-afa0-4177-80ef-c3ae9a78a4e1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sumatriptan succinate
Dosage form INJECTION
Route SUBCUTANEOUS
Labeler Alembic Pharmaceuticals Limited
Application ANDA213518
Marketing category ANDA
Marketing start 2025-11-06
Substance SUMATRIPTAN SUCCINATE
Active strength 4 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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A213518-001 SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) INJECTABLE / SUBCUTANEOUS AB 2025-11-06 A213518-002 SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS AB 2025-11-06
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.
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 A213518-001 SUMATRIPTAN SUCCINATE EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) INJECTABLE / SUBCUTANEOUS AB 2025-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213518-002 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS AB 2025-11-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213518-001 SUMATRIPTAN SUCCINATE EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) INJECTABLE / SUBCUTANEOUS AB 2025-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213518-002 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS AB 2025-11-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213518-001 SUMATRIPTAN SUCCINATE EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) INJECTABLE / SUBCUTANEOUS AB 2025-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213518-002 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS AB 2025-11-06 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213518-001 SUMATRIPTAN SUCCINATE EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) INJECTABLE / SUBCUTANEOUS AB 2025-11-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213518-002 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS AB 2025-11-06 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base SUMATRIPTAN SUCCINATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SUMATRIPTAN SUCCINATE 4 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1657151 Internal RxNorm lookup 1793916 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 46708-656-01 SUMATRIPTAN SUCCINATE 0.5 mL in 1 SYRINGE INJECTION 0.5 1 46708-656-01 SUMATRIPTAN SUCCINATE 2 in 1 CARTON INJECTION 2 1 46708-656-05 SUMATRIPTAN SUCCINATE 1 in 1 CARTON INJECTION 1 1 46708-656-05 SUMATRIPTAN SUCCINATE 0.5 mL in 1 SYRINGE INJECTION 0.5 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 46708-656-01 46708065601 2 SYRINGE in 1 CARTON (46708-656-01) / .5 mL in 1 SYRINGE 2 syringe 2025-11-06 No No Current 46708-656-05 46708065605 1 SYRINGE in 1 CARTON (46708-656-05) / .5 mL in 1 SYRINGE 1 syringe 2025-11-06 No No Current