Home NDC 61442-172 Cefaclor
Product NDC 61442-172
11-digit product format 614420172
Labeler code 61442
Product ID 61442-172_3417e20b-604b-3cdd-e063-6394a90ac707
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefaclor
Dosage form CAPSULE
Route ORAL
Labeler Carlsbad Technology, Inc.
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.
Product history page 1 of 3 · 82 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 2026-02-19 14:30 UTC 2026-02 A065146-001 CEFACLOR EQ 250MG BASE CAPSULE / ORAL 2004-01-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065146-002 CEFACLOR EQ 500MG BASE CAPSULE / ORAL RS 2004-01-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065146-001 CEFACLOR EQ 250MG BASE CAPSULE / ORAL 2004-01-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065146-002 CEFACLOR EQ 500MG BASE CAPSULE / ORAL RS 2004-01-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065146-001 CEFACLOR EQ 250MG BASE CAPSULE / ORAL 2004-01-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065146-002 CEFACLOR EQ 500MG BASE CAPSULE / ORAL RS 2004-01-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065146-001 CEFACLOR EQ 250MG BASE CAPSULE / ORAL 2004-01-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065146-002 CEFACLOR EQ 500MG BASE CAPSULE / ORAL RS 2004-01-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065146-001 CEFACLOR EQ 250MG BASE CAPSULE / ORAL 2004-01-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065146-002 CEFACLOR EQ 500MG BASE CAPSULE / ORAL RS 2004-01-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065146-001 CEFACLOR EQ 250MG BASE CAPSULE / ORAL 2004-01-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065146-002 CEFACLOR EQ 500MG BASE CAPSULE / ORAL RS 2004-01-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065146-001 CEFACLOR EQ 250MG BASE CAPSULE / ORAL 2004-01-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065146-002 CEFACLOR EQ 500MG BASE CAPSULE / ORAL RS 2004-01-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065146-001 CEFACLOR EQ 250MG BASE CAPSULE / ORAL 2004-01-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065146-002 CEFACLOR EQ 500MG BASE CAPSULE / ORAL RS 2004-01-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065146-001 CEFACLOR EQ 250MG BASE CAPSULE / ORAL 2004-01-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065146-002 CEFACLOR EQ 500MG BASE CAPSULE / ORAL RS 2004-01-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065146-001 CEFACLOR EQ 250MG BASE CAPSULE / ORAL 2004-01-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065146-002 CEFACLOR EQ 500MG BASE CAPSULE / ORAL RS 2004-01-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065146-001 CEFACLOR EQ 250MG BASE CAPSULE / ORAL 2004-01-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065146-002 CEFACLOR EQ 500MG BASE CAPSULE / ORAL RS 2004-01-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065146-001 CEFACLOR EQ 250MG BASE CAPSULE / ORAL 2004-01-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065146-002 CEFACLOR EQ 500MG BASE CAPSULE / ORAL RS 2004-01-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065146-001 CEFACLOR EQ 250MG BASE CAPSULE / ORAL 2004-01-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065146-002 CEFACLOR EQ 500MG BASE CAPSULE / ORAL RS 2004-01-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065146-001 CEFACLOR EQ 250MG BASE CAPSULE / ORAL 2004-01-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065146-002 CEFACLOR EQ 500MG BASE CAPSULE / ORAL RS 2004-01-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065146-001 CEFACLOR EQ 250MG BASE CAPSULE / ORAL AB 2004-01-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065146-002 CEFACLOR EQ 500MG BASE CAPSULE / ORAL AB 2004-01-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065146-001 CEFACLOR EQ 250MG BASE CAPSULE / ORAL AB 2004-01-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065146-002 CEFACLOR EQ 500MG BASE CAPSULE / ORAL AB 2004-01-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065146-001 CEFACLOR EQ 250MG BASE CAPSULE / ORAL AB 2004-01-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065146-002 CEFACLOR EQ 500MG BASE CAPSULE / ORAL AB 2004-01-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065146-001 CEFACLOR EQ 250MG BASE CAPSULE / ORAL AB 2004-01-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065146-002 CEFACLOR EQ 500MG BASE CAPSULE / ORAL AB 2004-01-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065146-001 CEFACLOR EQ 250MG BASE CAPSULE / ORAL AB 2004-01-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065146-002 CEFACLOR EQ 500MG BASE CAPSULE / ORAL AB 2004-01-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065146-001 CEFACLOR EQ 250MG BASE CAPSULE / ORAL AB 2004-01-22 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065146-002 CEFACLOR EQ 500MG BASE CAPSULE / ORAL AB 2004-01-22 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197449 Internal RxNorm lookup 309045 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 61442-172-01 Cefaclor 100 in 1 BOTTLE, PLASTIC CAPSULE 100 4 61442-172-05 Cefaclor 500 in 1 BOTTLE, PLASTIC CAPSULE 500 4 61442-172-30 Cefaclor 30 in 1 BOTTLE, PLASTIC CAPSULE 30 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEFACLOR ACTIVE INGREDIENT 69K7K19H4L CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.] 1 CEFACLOR ANHYDROUS ACTIVE MOIETY 3Z6FS3IK0K CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.] 1 alcohol INACTIVE INGREDIENT 3K9958V90M CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.] 1 ammonia INACTIVE INGREDIENT 5138Q19F1X CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.] 1 FD&C Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.] 1 FD&C Red No. 3 INACTIVE INGREDIENT PN2ZH5LOQY CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.] 1 FD&C Red No. 40 INACTIVE INGREDIENT WZB9127XOA CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.] 1 FD&C Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.] 1 gelatin INACTIVE INGREDIENT 2G86QN327L CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.] 1 isopropyl alcohol INACTIVE INGREDIENT ND2M416302 CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.] 1 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.] 1 potassium hydroxide INACTIVE INGREDIENT WZH3C48M4T CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.] 1 shellac INACTIVE INGREDIENT 46N107B71O CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.] 1 talc INACTIVE INGREDIENT 7SEV7J4R1U CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.] 1 tert-butyl alcohol INACTIVE INGREDIENT MD83SFE959 CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61442-172 CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.] 4 Current NDC, Legacy NDC, 3 package rows 20250503_2f61354e-bcb0-41aa-955f-51eabc11387b.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 · 2 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 61442-172-01 61442017201 100 CAPSULE in 1 BOTTLE, PLASTIC (61442-172-01) 100 capsule 2008-07-31 0000-00-00 No No Current 61442-172-05 61442017205 500 CAPSULE in 1 BOTTLE, PLASTIC (61442-172-05) 500 capsule 2008-07-31 0000-00-00 No No Current 61442-172-30 61442017230 30 CAPSULE in 1 BOTTLE, PLASTIC (61442-172-30) 30 capsule 2008-07-31 0000-00-00 No No Current