Clarithromycin

Product NDC: 68071-3116
Requested package NDC: 68071-3116-3
11-digit product format: 680713116
Labeler code: 68071
Product ID: 68071-3116_2abbae2e-2b8b-62d9-e063-6394a90a39b0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clarithromycin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA203584
Marketing category: ANDA
Marketing start: 2015-12-04
Substance: CLARITHROMYCIN
Active strength: 500 mg/1
Pharmacologic classes: Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68071-3116	68071-3116-3	D	Discontinued by firm		2026-08-03

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
A203584-001	CLARITHROMYCIN	CLARITHROMYCIN	250MG	TABLET / ORAL	AB		2015-09-28
A203584-002	CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET / ORAL	AB		2015-09-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A203584-001	AB
A203584-002	AB

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203584-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2015-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203584-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2015-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203584-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2015-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203584-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2015-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203584-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2015-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203584-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2015-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203584-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2015-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203584-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2015-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203584-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2015-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203584-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2015-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203584-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2015-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203584-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2015-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203584-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2015-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203584-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2015-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203584-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2015-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203584-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2015-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203584-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2015-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203584-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2015-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203584-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2015-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203584-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2015-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203584-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2015-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203584-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2015-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203584-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2015-09-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203584-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2015-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203584-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2015-09-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203584-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2015-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203584-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2015-09-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203584-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2015-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203584-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2015-09-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203584-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2015-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203584-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2015-09-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203584-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2015-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203584-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2015-09-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203584-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2015-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203584-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2015-09-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203584-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2015-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203584-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2015-09-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203584-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2015-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203584-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2015-09-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203584-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2015-09-28	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203584-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203584-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203584-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203584-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203584-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203584-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203584-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203584-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203584-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203584-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203584-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203584-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203584-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203584-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203584-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203584-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203584-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203584-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203584-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203584-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203584-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203584-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203584-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203584-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203584-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203584-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203584-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203584-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203584-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203584-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203584-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203584-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203584-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203584-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203584-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203584-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203584-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203584-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203584-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203584-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2bb254ff-3d7f-4bdb-abf9-476506008c55	Product name	1	20230117
e3d1ac4d-bee8-bcec-c4e6-12004dcb6ab2	Product name	7	20221114
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-3116-2	Clarithromycin	20 in 1 BOTTLE	TABLET, FILM COATED	20	8
68071-3116-3	Clarithromycin	30 in 1 BOTTLE	TABLET, FILM COATED	30	8
68071-3116-4	Clarithromycin	14 in 1 BOTTLE	TABLET, FILM COATED	14	8
68071-3116-8	Clarithromycin	28 in 1 BOTTLE	TABLET, FILM COATED	28	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3116	CLARITHROMYCIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]	8	Current NDC, Legacy NDC, 4 package rows	20250104_4a3febd5-8cf4-5306-e054-00144ff8d46c.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clarithromycin	CLARITHROMYCIN	Solaris Pharma Corporation	4d42821d-ce7a-7d64-e063-6294a90a0875	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203584 application number: ANDA203584
Clarithromycin	CLARITHROMYCIN	American Health Packaging	59ebe6cb-c830-45c7-8242-52f9f42a90a0	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203584 application number: ANDA203584
Clarithromycin	CLARITHROMYCIN	Proficient Rx LP	9eb306e0-ccfb-418c-82ca-204f20a788f7	2025-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203584 application number: ANDA203584
Clarithromycin	CLARITHROMYCIN	PD-Rx Pharmaceuticals, Inc.	1cb8a78a-0f07-49e8-a23e-a77628006209	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203584 application number: ANDA203584
Clarithromycin	CLARITHROMYCIN	Lannett Company, Inc.	9bf207c0-86eb-4f3b-92e7-f65f3fccd5a7	2023-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203584 application number: ANDA203584

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H1250JIK0A	CLARITHROMYCIN	81103-11-9	CLARITHROMYCIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197517	clarithromycin 500 MG Oral Tablet	PSN	4a3febd5-8cf4-5306-e054-00144ff8d46c	8
197517	clarithromycin 500 MG Oral Tablet	SCD	4a3febd5-8cf4-5306-e054-00144ff8d46c	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-3116-3	68071311603	30 TABLET, FILM COATED in 1 BOTTLE (68071-3116-3)	2017-03-08	0000-00-00	No	No	Current