Home NDC 50090-1602 Cefaclor
Product NDC 50090-1602
11-digit product format 500901602
Labeler code 50090
Product ID 50090-1602_bdfc38c7-4047-429b-a6c1-1100fc4caaaa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefaclor
Dosage form CAPSULE
Route ORAL
Labeler A-S Medication Solutions
Application ANDA065146
Marketing category ANDA
Marketing start 2008-07-31
Substance CEFACLOR
Active strength 500 mg/1
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065146-001 CEFACLOR CEFACLOR EQ 250MG BASE CAPSULE / ORAL 2004-01-22 A065146-002 CEFACLOR CEFACLOR EQ 500MG BASE CAPSULE / ORAL RS 2004-01-22
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 A065146-001 CEFACLOR EQ 250MG BASE CAPSULE / ORAL 2004-01-22 a50c72e98297…2026-08-01 22:54:32 2026-06 A065146-002 CEFACLOR EQ 500MG BASE CAPSULE / ORAL RS 2004-01-22 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 Cefaclor
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFACLOR 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 69K7K19H4L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197449 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 50090-1602-0 Cefaclor 30 in 1 BOTTLE CAPSULE 30 10 50090-1602-2 Cefaclor 21 in 1 BOTTLE CAPSULE 21 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-1602 CEFACLOR CAPSULE [A-S MEDICATION SOLUTIONS] 10 Current NDC, Legacy NDC, 2 package rows 20240201_d79a4b28-ef2b-4f0f-baec-002df7d06dd4.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 50090-1602-0 50090160200 30 CAPSULE in 1 BOTTLE (50090-1602-0) 30 capsule 2019-02-20 0000-00-00 No No Current 50090-1602-2 50090160202 21 CAPSULE in 1 BOTTLE (50090-1602-2) 21 capsule 2015-01-06 0000-00-00 No No Current