Cefaclor

Product NDC: 61442-176
11-digit product format: 614420176
Labeler code: 61442
Product ID: 61442-176_2632c343-21cc-4563-96b3-ac1f0c78dae6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefaclor
Dosage form: SUSPENSION
Route: ORAL
Labeler: Carlsbad Technology, Inc.
Application: ANDA065412
Marketing category: ANDA
Marketing start: 2012-03-27
Marketing end: 0000-00-00
Substance: CEFACLOR
Active strength: 375 mg/5mL
Pharmacologic classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61442-176		D	Discontinued by firm	2026-08-17
excluded package	package	61442-176	61442-176-01	D	Discontinued by firm	2026-08-17
excluded package	package	61442-176	61442-176-02	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 63 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61442-176-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61442-176-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61442-176-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61442-176-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61442-176-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61442-176-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61442-176-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61442-176-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61442-176-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61442-176-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61442-176-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61442-176-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61442-176-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61442-176-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61442-176-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61442-176-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61442-176-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61442-176-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61442-176-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61442-176-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61442-176-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61442-176-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61442-176-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61442-176-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61442-176-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61442-176-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61442-176-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61442-176-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61442-176-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61442-176-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61442-176-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61442-176-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61442-176-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61442-176-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61442-176-02	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61442-176-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61442-176-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61442-176-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61442-176-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61442-176-01	`e2bbac7714bc…`	`27bdfed8d636…`

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	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	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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61442-176-01	2020-01-31	C162847	48780-1	9d75b9d0-4ef4-f424-e053-dadaa90a57ce	Cefaclor for Oral Suspension, USP
61442-176-02	2020-01-31	C162847	48780-1	9d75b9d0-4ef4-f424-e053-dadaa90a57ce	Cefaclor for Oral Suspension, USP

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Cefaclor	ACTIVE INGREDIENT	69K7K19H4L	CEFACLOR SUSPENSION [CARLSBAD TECHNOLOGY, INC.]	3
Cefaclor Anhydrous	ACTIVE MOIETY	3Z6FS3IK0K	CEFACLOR SUSPENSION [CARLSBAD TECHNOLOGY, INC.]	3
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	CEFACLOR SUSPENSION [CARLSBAD TECHNOLOGY, INC.]	3
METHYLCELLULOSE (25 CPS)	INACTIVE INGREDIENT	BI55GG2WLI	CEFACLOR SUSPENSION [CARLSBAD TECHNOLOGY, INC.]	3
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	CEFACLOR SUSPENSION [CARLSBAD TECHNOLOGY, INC.]	3
sucrose	INACTIVE INGREDIENT	C151H8M554	CEFACLOR SUSPENSION [CARLSBAD TECHNOLOGY, INC.]	3
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	CEFACLOR SUSPENSION [CARLSBAD TECHNOLOGY, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61442-176	CEFACLOR SUSPENSION [CARLSBAD TECHNOLOGY, INC.]	3	Legacy NDC	20151021_9f919252-7a87-4386-a64c-5d8213f7e881.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	Azorian Pharma, LLC	224af904-38f3-4210-a750-e21006db4c66	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065412 application number: ANDA065412

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefaclor for Oral Suspension, USP	Carlsbad Technology, Inc. \| Yung Shin Pharmaceutical Industrual Co., Ltd. \| Yung Shin Pharmaceutical Industrial Co., Ltd.	2015-09-09	HUMAN PRESCRIPTION DRUG LABEL	3