Home NDC 81948-6250 Cefaclor
Product NDC 81948-6250
11-digit product format 819486250
Labeler code 81948
Product ID 81948-6250_a6a7fcf7-b9dc-4dac-b127-418588586a8a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cefaclor
Dosage form SUSPENSION
Route ORAL
Labeler Azorian Pharma, LLC
Application ANDA065412
Marketing category ANDA
Marketing start 2022-11-01
Substance CEFACLOR
Active strength 250 mg/5mL
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 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065412-001 CEFACLOR CEFACLOR EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 A065412-002 CEFACLOR CEFACLOR EQ 187MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 A065412-003 CEFACLOR CEFACLOR EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 A065412-004 CEFACLOR CEFACLOR EQ 375MG BASE/5ML FOR SUSPENSION / ORAL RS 2012-02-17
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.
Product history page 1 of 5 · 168 observed 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 2026-08-18 06:07:40 2026-07 A065412-001 CEFACLOR EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065412-002 CEFACLOR EQ 187MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065412-003 CEFACLOR EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065412-004 CEFACLOR EQ 375MG BASE/5ML FOR SUSPENSION / ORAL RS 2012-02-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065412-001 CEFACLOR EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065412-002 CEFACLOR EQ 187MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065412-003 CEFACLOR EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065412-004 CEFACLOR EQ 375MG BASE/5ML FOR SUSPENSION / ORAL RS 2012-02-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065412-001 CEFACLOR EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065412-002 CEFACLOR EQ 187MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065412-003 CEFACLOR EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065412-004 CEFACLOR EQ 375MG BASE/5ML FOR SUSPENSION / ORAL RS 2012-02-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065412-001 CEFACLOR EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065412-002 CEFACLOR EQ 187MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065412-003 CEFACLOR EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065412-004 CEFACLOR EQ 375MG BASE/5ML FOR SUSPENSION / ORAL RS 2012-02-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065412-001 CEFACLOR EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065412-002 CEFACLOR EQ 187MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065412-003 CEFACLOR EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065412-004 CEFACLOR EQ 375MG BASE/5ML FOR SUSPENSION / ORAL RS 2012-02-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065412-001 CEFACLOR EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065412-002 CEFACLOR EQ 187MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065412-003 CEFACLOR EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065412-004 CEFACLOR EQ 375MG BASE/5ML FOR SUSPENSION / ORAL RS 2012-02-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065412-001 CEFACLOR EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065412-002 CEFACLOR EQ 187MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065412-003 CEFACLOR EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065412-004 CEFACLOR EQ 375MG BASE/5ML FOR SUSPENSION / ORAL RS 2012-02-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065412-001 CEFACLOR EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065412-002 CEFACLOR EQ 187MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065412-003 CEFACLOR EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065412-004 CEFACLOR EQ 375MG BASE/5ML FOR SUSPENSION / ORAL RS 2012-02-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065412-001 CEFACLOR EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065412-002 CEFACLOR EQ 187MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065412-003 CEFACLOR EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065412-004 CEFACLOR EQ 375MG BASE/5ML FOR SUSPENSION / ORAL RS 2012-02-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065412-001 CEFACLOR EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065412-002 CEFACLOR EQ 187MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065412-003 CEFACLOR EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065412-004 CEFACLOR EQ 375MG BASE/5ML FOR SUSPENSION / ORAL RS 2012-02-17 d8e5a09893c0…
Additional Listing Data#
Finished product Yes
Brand name base Cefaclor
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFACLOR 250 mg/5mL
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 313888 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 81948-6250-1 Cefaclor 150 mL in 1 BOTTLE SUSPENSION 150 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81948-6250 CEFACLOR SUSPENSION [AZORIAN PHARMA, LLC] 1 Current NDC, Legacy NDC, 1 package rows 20221109_224af904-38f3-4210-a750-e21006db4c66.zip
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.
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 81948-6250-1 81948625001 150 mL in 1 BOTTLE (81948-6250-1) 150 ml 2022-11-01 0000-00-00 No No Current