Cefaclor

Product NDC: 0093-1087
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 42.

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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`bb7c543d1eb4…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0878bdc2-0410-4938-9890-96523aa81c2f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
57d340b5-4768-6bd5-e047-9a70a6cc1ce7	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-1087-01	EA - Each	0093-1087	7335c3e6-1e74-4351-9fc7-63dcd788a458	1	2012-07-24

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

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefaclor	CEFACLOR	Teva Pharmaceuticals USA, Inc.	0878bdc2-0410-4938-9890-96523aa81c2f	2019-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065058 application number: ANDA065058 ndc (product): 0093-1087

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
69K7K19H4L	CEFACLOR	70356-03-5	CEFACLOR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309043	cefaclor 500 MG 12HR Extended Release Oral Tablet	PSN	0878bdc2-0410-4938-9890-96523aa81c2f	11
309043	12 HR cefaclor 500 MG Extended Release Oral Tablet	SCD	0878bdc2-0410-4938-9890-96523aa81c2f	11
309043	cefaclor 500 MG 12 HR Extended Release Oral Tablet	SY	0878bdc2-0410-4938-9890-96523aa81c2f	11

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CEFACLOR EXTENDED-RELEASE TABLETS USP Rx only	Teva Pharmaceuticals USA, Inc.	2019-07-31	HUMAN PRESCRIPTION DRUG LABEL	11