Home NDC 83854-048 FLUORESCEIN
Product NDC 83854-048
11-digit product format 838540048
Labeler code 83854
Product ID 83854-048_5c448a5e-458f-469c-9f1f-417c051b5c15
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluorescein
Dosage form INJECTION
Route INTRAVENOUS
Labeler Anthea Pharma Private Limited
Application ANDA218651
Marketing category ANDA
Marketing start 2026-10-14
Substance FLUORESCEIN SODIUM
Active strength 100 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 44 .
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 2026-10-15 13:18:30 2026-09 A218651-001 FLUORESCEIN SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2026-06-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 A218651-002 FLUORESCEIN SODIUM EQ 500MG BASE/2ML (EQ 250MG BASE/ML) INJECTABLE / INTRAVENOUS RS 2026-06-01 c2088c7a36db…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# 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 100 mg/mL
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 Marketing start Sample Exclude flag Status 83854-048-12 83854004812 12 VIAL, SINGLE-DOSE in 1 CARTON (83854-048-12) / 5 mL in 1 VIAL, SINGLE-DOSE (83854-048-01) 2026-10-14 No No Current