Home NDC 68071-1650-5 Sulfacetamide Sodium and Prednisolone Sodium Phosphate
Product NDC 68071-1650
Requested package NDC 68071-1650-5
11-digit product format 680711650
Labeler code 68071
Product ID 68071-1650_1d4de4f7-e86f-d269-e063-6294a90ab688
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sulfacetamide Sodium and Prednisolone Sodium Phosphate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA074449
Marketing category ANDA
Marketing start 1995-12-29
Substance PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM
Active strength 2.3; 100 mg/mL; mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
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 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074449-001 SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM EQ 0.23% PHOSPHATE;10% SOLUTION/DROPS / OPHTHALMIC RS 1995-12-29
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 2026-08-01 22:54:32 2026-06 A074449-001 SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE EQ 0.23% PHOSPHATE;10% SOLUTION/DROPS / OPHTHALMIC RS 1995-12-29 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Sulfacetamide Sodium and Prednisolone Sodium Phosphate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULFACETAMIDE SODIUM 2.3 mg/mL PREDNISOLONE SODIUM PHOSPHATE 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4NRT660KJQ Internal UNII lookup IV021NXA9J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1012021 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-1650-5 Sulfacetamide Sodium and Prednisolone Sodium Phosphate 5 mL in 1 BOX SOLUTION/ DROPS 5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-1650 SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [NUCARE PHARMACEUTICALS,INC.] 4 Current NDC, Legacy NDC, 1 package rows 20240716_835def0b-ed5a-61a0-e053-2a91aa0ae7ae.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68071-1650-5 68071165005 5 mL in 1 BOX (68071-1650-5) 5 ml 2019-03-05 0000-00-00 No No Current