Home NDC 0093-1087-01 Cefaclor
Product NDC 0093-1087
Requested package NDC 0093-1087-01
11-digit product format 000931087
Labeler code 0093
Product ID 0093-1087_61ec00e0-d37d-4aa4-8f50-031ee7a37ecc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefaclor
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA065058
Marketing category ANDA
Marketing start 2002-09-26
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 A065058-001 CEFACLOR CEFACLOR EQ 375MG BASE TABLET, EXTENDED RELEASE / ORAL 2002-09-04 A065058-002 CEFACLOR CEFACLOR EQ 500MG BASE TABLET, EXTENDED RELEASE / ORAL RS 2002-09-04
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 A065058-001 CEFACLOR EQ 375MG BASE TABLET, EXTENDED RELEASE / ORAL 2002-09-04 a50c72e98297…2026-08-01 22:54:32 2026-06 A065058-002 CEFACLOR EQ 500MG BASE TABLET, EXTENDED RELEASE / ORAL RS 2002-09-04 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 · 1 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 309043 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0093-1087-01 Cefaclor 100 in 1 BOTTLE TABLET, FILM COATED, EXTENDED RE 100 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-1087 CEFACLOR TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA, INC.] 11 Current NDC, Legacy NDC, 1 package rows 20210520_0878bdc2-0410-4938-9890-96523aa81c2f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0093-1087-01 00093108701 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-1087-01) 2002-09-26 0000-00-00 No No Current