Cefaclor

Product NDC: 50090-1602
11-digit product format: 500901602
Labeler code: 50090
Product ID: 50090-1602_bdfc38c7-4047-429b-a6c1-1100fc4caaaa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefaclor
Dosage form: CAPSULE
Route: ORAL
Labeler: A-S Medication Solutions
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 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
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 · 84 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	A065146-001	CEFACLOR	EQ 250MG BASE	CAPSULE / ORAL			2004-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065146-002	CEFACLOR	EQ 500MG BASE	CAPSULE / ORAL		RS	2004-01-22	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065146-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065146-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065146-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065146-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065146-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065146-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065146-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065146-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065146-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065146-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065146-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065146-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065146-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065146-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065146-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065146-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065146-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065146-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065146-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065146-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065146-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065146-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065146-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065146-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065146-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065146-002	AB	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A065146-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A065146-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065146-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065146-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065146-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065146-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065146-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065146-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065146-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065146-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065146-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A065146-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065146-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A065146-002	AB	1	`3bdfa0b2c4d7…`

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
197449	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
d79a4b28-ef2b-4f0f-baec-002df7d06dd4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
57d340b5-4768-6bd5-e047-9a70a6cc1ce7	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-1602-0	2023-02-07	Cefaclor Capsules USP
50090-1602-2	2023-02-07	Cefaclor Capsules USP
50090-1602-0	2023-01-30	Cefaclor Capsules USP
50090-1602-2	2023-01-30	Cefaclor Capsules USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-1602-0	Cefaclor	30 in 1 BOTTLE	CAPSULE	30		10
50090-1602-2	Cefaclor	21 in 1 BOTTLE	CAPSULE	21		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-1602-0	EA - Each	50090-1602	1a99ee91-7cf0-448e-aa01-7cc1b4b53803	1	2021-09-07
50090-1602-2	EA - Each	50090-1602	50a62d4b-a673-4971-84c2-cc93906e1845	1	2021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-1602	CEFACLOR CAPSULE [A-S MEDICATION SOLUTIONS]	10	Current NDC, Legacy NDC, 2 package rows	20240201_d79a4b28-ef2b-4f0f-baec-002df7d06dd4.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefaclor	CEFACLOR	Carlsbad Technology, Inc.	2f61354e-bcb0-41aa-955f-51eabc11387b	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065146 application number: ANDA065146
Cefaclor	CEFACLOR	A-S Medication Solutions	d79a4b28-ef2b-4f0f-baec-002df7d06dd4	2024-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065146 application number: ANDA065146 ndc (product): 50090-1602

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
197449	cefaclor 500 MG Oral Capsule	PSN	d79a4b28-ef2b-4f0f-baec-002df7d06dd4	10
197449	cefaclor 500 MG Oral Capsule	SCD	d79a4b28-ef2b-4f0f-baec-002df7d06dd4	10
197449	cefaclor (as cefaclor monohydrate) 500 MG Oral Capsule	SY	d79a4b28-ef2b-4f0f-baec-002df7d06dd4	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-1602-0	50090160200	30 CAPSULE in 1 BOTTLE (50090-1602-0)	30 capsule	2019-02-20	0000-00-00	No	No	Current
50090-1602-2	50090160202	21 CAPSULE in 1 BOTTLE (50090-1602-2)	21 capsule	2015-01-06	0000-00-00	No	No	Current