FDA.reportPublic FDA data

Fluorescein

Product NDC
70710-2045
Requested package NDC
70710-2045-9
11-digit product format
707102045
Labeler code
70710
Product ID
70710-2045_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
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 43.

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
2026-09-14 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
2026-09-14 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…

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
IngredientStrength
FLUORESCEIN SODIUM100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
93X55PE38XInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
19aea137-3f47-4b69-9884-3bff5f79b04aAvailable on FDA.report

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

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluoresceinFLUORESCEINZydus Lifesciences Limited5c88e2a2-b05c-46f2-9874-c935e4b96a6e2026-06-02Exact identifier
application applno (ANDA): 218651
application number: ANDA218651
FluoresceinFLUORESCEINZydus Pharmaceuticals USA Inc.19aea137-3f47-4b69-9884-3bff5f79b04a2026-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218651
application number: ANDA218651
ndc (package): 70710-2045-9
ndc (product): 70710-2045
ndc11 (package): 70710204509

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70710-2045-97071020450912 VIAL, SINGLE-DOSE in 1 CARTON (70710-2045-9) / 5 mL in 1 VIAL, SINGLE-DOSE (70710-2045-1) 2026-06-02NoNoCurrent