Clarithromycin

Product NDC: 27241-065
11-digit product format: 272410065
Labeler code: 27241
Product ID: 27241-065_868d0295-b174-468c-a684-7c25d37ed9bd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clarithromycin
Dosage form: TABLET
Route: ORAL
Labeler: Ajanta Pharma USA Inc.
Application: ANDA206714
Marketing category: ANDA
Marketing start: 2019-04-25
Marketing end: 0000-00-00
Substance: CLARITHROMYCIN
Active strength: 500 mg/1
Pharmacologic classes: Macrolide Antimicrobial [EPC],Macrolides [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	27241-065		I	Inactivated by FDA		2026-08-03
excluded package	package	27241-065	27241-065-06	I	Inactivated by FDA		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
A206714-001	CLARITHROMYCIN	CLARITHROMYCIN	250MG	TABLET / ORAL			2019-04-25
A206714-002	CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET / ORAL			2019-04-25

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206714-001	CLARITHROMYCIN	250MG	TABLET / ORAL	2019-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206714-002	CLARITHROMYCIN	500MG	TABLET / ORAL	2019-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206714-001	CLARITHROMYCIN	250MG	TABLET / ORAL	2019-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206714-002	CLARITHROMYCIN	500MG	TABLET / ORAL	2019-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206714-001	CLARITHROMYCIN	250MG	TABLET / ORAL	2019-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206714-002	CLARITHROMYCIN	500MG	TABLET / ORAL	2019-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206714-001	CLARITHROMYCIN	250MG	TABLET / ORAL	2019-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206714-002	CLARITHROMYCIN	500MG	TABLET / ORAL	2019-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206714-001	CLARITHROMYCIN	250MG	TABLET / ORAL	2019-04-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206714-002	CLARITHROMYCIN	500MG	TABLET / ORAL	2019-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206714-001	CLARITHROMYCIN	250MG	TABLET / ORAL	2019-04-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206714-002	CLARITHROMYCIN	500MG	TABLET / ORAL	2019-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206714-001	CLARITHROMYCIN	250MG	TABLET / ORAL	2019-04-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206714-002	CLARITHROMYCIN	500MG	TABLET / ORAL	2019-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206714-001	CLARITHROMYCIN	250MG	TABLET / ORAL	2019-04-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206714-002	CLARITHROMYCIN	500MG	TABLET / ORAL	2019-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206714-001	CLARITHROMYCIN	250MG	TABLET / ORAL	2019-04-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206714-002	CLARITHROMYCIN	500MG	TABLET / ORAL	2019-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206714-001	CLARITHROMYCIN	250MG	TABLET / ORAL	2019-04-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206714-002	CLARITHROMYCIN	500MG	TABLET / ORAL	2019-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206714-001	CLARITHROMYCIN	250MG	TABLET / ORAL	2019-04-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206714-002	CLARITHROMYCIN	500MG	TABLET / ORAL	2019-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206714-001	CLARITHROMYCIN	250MG	TABLET / ORAL	2019-04-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206714-002	CLARITHROMYCIN	500MG	TABLET / ORAL	2019-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206714-001	CLARITHROMYCIN	250MG	TABLET / ORAL	2019-04-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206714-002	CLARITHROMYCIN	500MG	TABLET / ORAL	2019-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206714-001	CLARITHROMYCIN	250MG	TABLET / ORAL	2019-04-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206714-002	CLARITHROMYCIN	500MG	TABLET / ORAL	2019-04-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206714-001	CLARITHROMYCIN	250MG	TABLET / ORAL	2019-04-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206714-002	CLARITHROMYCIN	500MG	TABLET / ORAL	2019-04-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206714-001	CLARITHROMYCIN	250MG	TABLET / ORAL	2019-04-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206714-002	CLARITHROMYCIN	500MG	TABLET / ORAL	2019-04-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206714-001	CLARITHROMYCIN	250MG	TABLET / ORAL	2019-04-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206714-002	CLARITHROMYCIN	500MG	TABLET / ORAL	2019-04-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206714-001	CLARITHROMYCIN	250MG	TABLET / ORAL	2019-04-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206714-002	CLARITHROMYCIN	500MG	TABLET / ORAL	2019-04-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206714-001	CLARITHROMYCIN	250MG	TABLET / ORAL	2019-04-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206714-002	CLARITHROMYCIN	500MG	TABLET / ORAL	2019-04-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206714-001	CLARITHROMYCIN	250MG	TABLET / ORAL	2019-04-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206714-002	CLARITHROMYCIN	500MG	TABLET / ORAL	2019-04-25	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A206714-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206714-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206714-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206714-002	AB	1	`ea99ee380514…`

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
27241-065-06	Clarithromycin	60 in 1 BOTTLE	TABLET	60		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27241-065	CLARITHROMYCIN TABLET [AJANTA PHARMA USA INC.]	8	Legacy NDC, 1 package rows	20231220_98580dee-d2f4-4f62-a2d4-7434bab2421e.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
197516	clarithromycin 250 MG Oral Tablet	PSN	98580dee-d2f4-4f62-a2d4-7434bab2421e	8
197517	clarithromycin 500 MG Oral Tablet	PSN	98580dee-d2f4-4f62-a2d4-7434bab2421e	8
197516	clarithromycin 250 MG Oral Tablet	SCD	98580dee-d2f4-4f62-a2d4-7434bab2421e	8
197517	clarithromycin 500 MG Oral Tablet	SCD	98580dee-d2f4-4f62-a2d4-7434bab2421e	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
27241-065-06	27241006506	60 TABLET in 1 BOTTLE (27241-065-06)	60 tablet	2019-04-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clarithromycin	Ajanta Pharma USA Inc. \| Ajanta Pharma Limited, Paithan	2023-12-05	Human Prescription Drug Label	8