CLARITHROMYCIN

Product NDC: 61919-643
11-digit product format: 619190643
Labeler code: 61919
Product ID: 61919-643_ea4ead5d-457a-2d81-e053-2a95a90abe5b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CLARITHROMYCIN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Direct_Rx
Application: ANDA203584
Marketing category: ANDA
Marketing start: 2019-08-12
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-643		I	Inactivated by FDA	2026-08-10
excluded product	product	61919-643		I	Inactivated by FDA	2026-08-10
excluded package	package	61919-643	61919-643-28	I	Inactivated by FDA	2026-08-10
excluded package	package	61919-643	61919-643-10	I	Inactivated by FDA	2026-08-10
excluded package	package	61919-643	61919-643-20	I	Inactivated by FDA	2026-08-10

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 · 45 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-643-20	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-643-28	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-643-10	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-643-20	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-643-28	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-643-10	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-643-20	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-643-28	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-643-10	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-643-20	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-643-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-643-10	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-643-20	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-643-28	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-643-10	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-643-20	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-643-28	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-643-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-643-20	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-643-10	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-643-28	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-643-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-643-10	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-643-28	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-643-20	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-643-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-643-28	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-643-10	2025-01-30	C162847	48780-1	2cef2736-abb6-d83d-e063-dadaa90ab31f	CLARITHROMYCIN
61919-643-20	2025-01-30	C162847	48780-1	2cef2736-abb6-d83d-e063-dadaa90ab31f	CLARITHROMYCIN
61919-643-28	2025-01-30	C162847	48780-1	2cef2736-a977-d83d-e063-dadaa90ab31f	CLARITHROMYCIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-643-10	CLARITHROMYCIN	10 in 1 BOTTLE	TABLET, FILM COATED	10	4
61919-643-20	CLARITHROMYCIN	20 in 1 BOTTLE	TABLET, FILM COATED	20	4
61919-643-28	CLARITHROMYCIN	28 in 1 BOTTLE	TABLET, FILM COATED	28	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-643-10	EA - Each	61919-643	e1fa3f87-5d42-4097-af98-8ec56e773364	1	2019-09-05
61919-643-20	EA - Each	61919-643	73581a9e-24c9-4807-85b3-889ae94d169e	1	2019-12-10
61919-643-28	EA - Each	61919-643	0408eb2a-cbd4-4576-94d2-67f04072dd34	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-643	CLARITHROMYCIN TABLET, FILM COATED [DIRECT_RX]	4	Legacy NDC, 2 package rows	20230511_8ff1fc34-9cd8-ea26-e053-2995a90a0616.zip
61919-643	CLARITHROMYCIN TABLET, FILM COATED [DIRECTRX]	1	Legacy NDC, 1 package rows	20190426_876b7723-ff80-7ccf-e053-2995a90a6fc3.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	8ff1fc34-9cd8-ea26-e053-2995a90a0616	4
197517	clarithromycin 500 MG Oral Tablet	SCD	8ff1fc34-9cd8-ea26-e053-2995a90a0616	4
197517	clarithromycin 500 MG Oral Tablet	PSN	876b7723-ff80-7ccf-e053-2995a90a6fc3	1
197517	clarithromycin 500 MG Oral Tablet	SCD	876b7723-ff80-7ccf-e053-2995a90a6fc3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-643-10	61919064310	10 TABLET, FILM COATED in 1 BOTTLE (61919-643-10)	2019-08-12	0000-00-00	No	No	Current
61919-643-20	61919064320	20 TABLET, FILM COATED in 1 BOTTLE (61919-643-20)	2019-11-06	0000-00-00	No	No	Current
61919-643-28	61919064328	28 TABLET, FILM COATED in 1 BOTTLE (61919-643-28)	2019-04-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLARITHROMYCIN	Direct_Rx	2023-05-10	HUMAN PRESCRIPTION DRUG LABEL	4
CLARITHROMYCIN	DirectRX \| DirectTRX	2019-04-26	HUMAN PRESCRIPTION DRUG LABEL	1