FDA.reportPublic FDA data

Fluorescein Injection, USP

Manufacturer
Zydus Lifesciences Limited | Zydus Lifesciences Global FZE
Effective date
2026-06-02
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-04 05:10:27

Label at a glance#

ProductFluorescein
Active ingredientFLUORESCEIN SODIUM
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1969-1

Fluorescein Injection, USP 10%

500 mg/5 mL (100 mg/mL)

Sterile Single-dose Vial

For Intravenous Injection

Discard unused portion.

Rx only

Zydus

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1970-1

Fluorescein Injection, USP 25%

500 mg/2 mL (250 mg/mL)

Sterile Single-dose Vial

For Intravenous Injection

Discard unused portion.

Rx only

Zydus

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FLUORESCEIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeDataBar Omni(01)00370710204518GTIN-14: 00370710204518
GTIN-12: 370710204518
UPC-A: 370710204518
EAN-13: 0370710204518
GTIN storage (14 digits): 00370710204518		1fa59f77-0f1a-4b92-b438-1b20853c967d-01.jpg
BarcodeDataBar Omni(01)00370710204617GTIN-14: 00370710204617
GTIN-12: 370710204617
UPC-A: 370710204617
EAN-13: 0370710204617
GTIN storage (14 digits): 00370710204617		1fa59f77-0f1a-4b92-b438-1b20853c967d-02.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8f43a274-9585-47cb-b427-0eb3e578384dProduct name120250623
4a998fa9-995e-4ea5-97ef-93a559305758Product name120200706
c94ccba7-2a03-4a3e-a891-d62a57340fb2Product name120180215

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-196970771-1969-1, 70771-1969-9
70771-197070771-1970-1, 70771-1970-9

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
FLUORESCEIN SODIUM93X55PE38XACTIM
HYDROCHLORIC ACIDQTT17582CBIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
FLUORESCEIN SODIUM93X55PE38XACTIM
HYDROCHLORIC ACIDQTT17582CBIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218651-001FLUORESCEIN SODIUMFLUORESCEIN SODIUMEQ 500MG BASE/5ML (EQ 100MG BASE/ML)INJECTABLE / INTRAVENOUSAP2026-06-01
A218651-002FLUORESCEIN SODIUMFLUORESCEIN SODIUMEQ 500MG BASE/2ML (EQ 250MG BASE/ML)INJECTABLE / INTRAVENOUSRS2026-06-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A218651-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A218651-001FLUORESCEIN SODIUMEQ 500MG BASE/5ML (EQ 100MG BASE/ML)INJECTABLE / INTRAVENOUSAP2026-06-01c2088c7a36db…
2026-10-15 13:18:302026-09A218651-002FLUORESCEIN SODIUMEQ 500MG BASE/2ML (EQ 250MG BASE/ML)INJECTABLE / INTRAVENOUSRS2026-06-01c2088c7a36db…
2026-09-14 22:38:342026-08A218651-001FLUORESCEIN SODIUMEQ 500MG BASE/5ML (EQ 100MG BASE/ML)INJECTABLE / INTRAVENOUSAP2026-06-0184e616aacf4f…
2026-09-14 22:38:342026-08A218651-002FLUORESCEIN SODIUMEQ 500MG BASE/2ML (EQ 250MG BASE/ML)INJECTABLE / INTRAVENOUSRS2026-06-0184e616aacf4f…
2026-08-18 06:07:402026-07A218651-001FLUORESCEIN SODIUMEQ 500MG BASE/5ML (EQ 100MG BASE/ML)INJECTABLE / INTRAVENOUSAP2026-06-01caaa826d4ba7…
2026-08-18 06:07:402026-07A218651-002FLUORESCEIN SODIUMEQ 500MG BASE/2ML (EQ 250MG BASE/ML)INJECTABLE / INTRAVENOUSRS2026-06-01caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218651-001FLUORESCEIN SODIUMEQ 500MG BASE/5ML (EQ 100MG BASE/ML)INJECTABLE / INTRAVENOUSAP2026-06-01a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218651-002FLUORESCEIN SODIUMEQ 500MG BASE/2ML (EQ 250MG BASE/ML)INJECTABLE / INTRAVENOUSRS2026-06-01a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A218651-001AP1c2088c7a36db…
2026-09-14 22:38:342026-08A218651-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A218651-001AP1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218651-001AP1a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluoresceinFLUORESCEINZydus Lifesciences Limited5c88e2a2-b05c-46f2-9874-c935e4b96a6e2026-06-02Exact identifier
ndc (package): 70771-1970-1
ndc (package): 70771-1969-9
ndc (package): 70771-1970-9
ndc (package): 70771-1969-1
ndc (product): 70771-1969
ndc (product): 70771-1970
ndc11 (package): 70771196909
ndc11 (package): 70771197001
ndc11 (package): 70771197009
ndc11 (package): 70771196901
spl id: 1fa59f77-0f1a-4b92-b438-1b20853c967d
spl set id: 5c88e2a2-b05c-46f2-9874-c935e4b96a6e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.