Clarithromycin

Product NDC: 68071-3116
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68071-3116		D	Discontinued by firm	2026-08-03
excluded package	package	68071-3116	68071-3116-2	D	Discontinued by firm	2026-08-03
excluded package	package	68071-3116	68071-3116-3	D	Discontinued by firm	2026-08-03
excluded package	package	68071-3116	68071-3116-4	D	Discontinued by firm	2026-08-03
excluded package	package	68071-3116	68071-3116-8	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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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
68071-3116-2	68071311602	20 TABLET, FILM COATED in 1 BOTTLE (68071-3116-2)	2017-03-08	0000-00-00	No	No	Current
68071-3116-3	68071311603	30 TABLET, FILM COATED in 1 BOTTLE (68071-3116-3)	2017-03-08	0000-00-00	No	No	Current
68071-3116-4	68071311604	14 TABLET, FILM COATED in 1 BOTTLE (68071-3116-4)	2017-03-08	0000-00-00	No	No	Current
68071-3116-8	68071311608	28 TABLET, FILM COATED in 1 BOTTLE (68071-3116-8)	2017-03-08	0000-00-00	No	No	Current