Clarithromycin

Product NDC: 65862-225
Requested package NDC: 65862-225-22
11-digit product format: 658620225
Labeler code: 65862
Product ID: 65862-225_4bb3048c-0a75-4818-9be5-4c81cfe9649c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clarithromycin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA065489
Marketing category: ANDA
Marketing start: 2012-07-25
Substance: CLARITHROMYCIN
Active strength: 250 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
unfinished package	package	65862-225	65862-225-22	UNFINISHED	Active or certified unfinished drug listing		2026-08-03

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 1 · 21 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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
A065489-001	CLARITHROMYCIN	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25
A065489-002	CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065489-001	AB
A065489-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`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	A065489-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065489-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065489-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065489-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065489-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065489-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065489-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065489-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065489-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065489-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065489-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065489-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065489-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065489-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065489-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065489-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065489-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065489-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065489-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065489-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065489-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065489-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065489-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065489-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065489-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065489-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065489-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065489-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065489-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065489-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065489-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065489-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065489-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065489-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065489-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065489-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065489-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065489-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065489-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065489-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Clarithromycin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLARITHROMYCIN	250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
H1250JIK0A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197516	Internal RxNorm lookup
197517	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
9aaffb41-408c-4372-8fd5-1d649450c0e9	Available on FDA.report

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	Strength	SPL version
65862-225-60	Clarithromycin	60 in 1 BOTTLE	TABLET, FILM COATED	60		21
65862-225-99	Clarithromycin	1000 in 1 BOTTLE	TABLET, FILM COATED	1000		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-225-60	EA - Each	65862-225	17d2f154-09f0-4ac6-9f9f-2c3102676107	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLARITHROMYCIN	ACTIVE INGREDIENT	H1250JIK0A	CLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	8
CLARITHROMYCIN	ACTIVE MOIETY	H1250JIK0A	CLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	8
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	8
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	CLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	8
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	CLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	8
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	CLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	8
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	8
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	CLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	8
VANILLIN	INACTIVE INGREDIENT	CHI530446X	CLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-225	CLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	21	Current NDC, Legacy NDC, 2 package rows	20231122_9aaffb41-408c-4372-8fd5-1d649450c0e9.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clarithromycin	CLARITHROMYCIN	Sportpharm LLC	d836ae7e-fdbf-4dcb-a90d-ede1dcbc3e67	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	REMEDYREPACK INC.	9d5848f0-e9f0-4112-a7ca-bcc8ea2e69c6	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	Proficient Rx LP	88c7ded8-333c-408d-b693-a72881710f59	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	Preferred Pharmaceuticals Inc.	81c0c69e-b1ae-42f3-9e85-09b8daa75d8d	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	Major Pharmaceuticals	d0a66646-6774-4fc6-9b26-a98c3a5df274	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	American Health Packaging	fa69ea92-0b41-43fb-918f-ed80e0dedf04	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	AvPAK	1920f943-bbf1-cfd9-7475-96a35680a9e0	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	Northwind Health Company, LLC	471f638a-9dd1-09d3-e063-6294a90a2d4f	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	Direct_Rx	3ba1da51-ba5b-323f-e063-6294a90a0333	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	PD-Rx Pharmaceuticals, Inc.	ba216276-b0bd-420a-9e0d-090bdfcc2460	2025-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	A-S Medication Solutions	25debd85-0840-4f8d-9898-027772061dd2	2025-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	NuCare Pharmaceuticals,Inc.	9143b79c-4c79-43ac-e053-2995a90ad708	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	Bryant Ranch Prepack	0c7d8391-50ef-4827-abe6-e0fc0c2f1636	2024-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	Rising Pharma Holdings, Inc.	0c4db97f-f4c9-4cac-9f12-9db1d967ebeb	2024-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	Aurobindo Pharma Limited	9aaffb41-408c-4372-8fd5-1d649450c0e9	2023-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489 ndc (product): 65862-225
Clarithromycin	CLARITHROMYCIN	A-S Medication Solutions	1d6f5a9d-51b2-4e0d-b573-ccf08fe6ea23	2023-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	Proficient Rx LP	b1bdf526-4f16-4130-b614-4cb678f060d7	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489

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
197516	clarithromycin 250 MG Oral Tablet	PSN	9aaffb41-408c-4372-8fd5-1d649450c0e9	21
197517	clarithromycin 500 MG Oral Tablet	PSN	9aaffb41-408c-4372-8fd5-1d649450c0e9	21
197516	clarithromycin 250 MG Oral Tablet	SCD	9aaffb41-408c-4372-8fd5-1d649450c0e9	21
197517	clarithromycin 500 MG Oral Tablet	SCD	9aaffb41-408c-4372-8fd5-1d649450c0e9	21
197516	clarithromycin 250 MG Oral Tablet	PSN	1d6f5a9d-51b2-4e0d-b573-ccf08fe6ea23	4
197516	clarithromycin 250 MG Oral Tablet	SCD	1d6f5a9d-51b2-4e0d-b573-ccf08fe6ea23	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
65862-225-22	65862022522	2000 TABLET, FILM COATED in 1 BAG (65862-225-22)	25-JUL-12	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clarithromycin	Sportpharm LLC	2026-06-24	HUMAN PRESCRIPTION DRUG LABEL	1
Clarithromycin	Aurobindo Pharma Limited	2023-10-10	Human Prescription Drug Label	21
Clarithromycin	A-S Medication Solutions	2023-07-31	Human Prescription Drug Label	4