Home NDC 70710-2046 Fluorescein
Product NDC 70710-2046
11-digit product format 707102046
Labeler code 70710
Product ID 70710-2046_3d7bac75-0d7d-46aa-8f0d-60bda9b2e380
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluorescein
Dosage form INJECTION
Route INTRAVENOUS
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA218651
Marketing category ANDA
Marketing start 2026-06-02
Substance FLUORESCEIN SODIUM
Active strength 250 mg/mL
Pharmacologic classes Diagnostic Dye [EPC], Dyes [MoA]
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 A218651-001 FLUORESCEIN SODIUM FLUORESCEIN SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2026-06-01 A218651-002 FLUORESCEIN SODIUM FLUORESCEIN SODIUM EQ 500MG BASE/2ML (EQ 250MG BASE/ML) INJECTABLE / INTRAVENOUS RS 2026-06-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218651-001 AP
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 2026-09-14 22:38:34 2026-08 A218651-001 FLUORESCEIN SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2026-06-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218651-002 FLUORESCEIN SODIUM EQ 500MG BASE/2ML (EQ 250MG BASE/ML) INJECTABLE / INTRAVENOUS RS 2026-06-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218651-001 FLUORESCEIN SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2026-06-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218651-002 FLUORESCEIN SODIUM EQ 500MG BASE/2ML (EQ 250MG BASE/ML) INJECTABLE / INTRAVENOUS RS 2026-06-01 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218651-001 FLUORESCEIN SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2026-06-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218651-002 FLUORESCEIN SODIUM EQ 500MG BASE/2ML (EQ 250MG BASE/ML) INJECTABLE / INTRAVENOUS RS 2026-06-01 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A218651-001 AP 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218651-001 AP 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218651-001 AP 1 a50c72e98297…
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 Fluorescein
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUORESCEIN SODIUM 250 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 93X55PE38X Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# 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 Marketing start Sample Exclude flag Status 70710-2046-9 70710204609 12 VIAL, SINGLE-DOSE in 1 CARTON (70710-2046-9) / 2 mL in 1 VIAL, SINGLE-DOSE (70710-2046-1) 2026-06-02 No No Current