Clarithromycin

Product NDC: 21695-558
11-digit product format: 216950558
Labeler code: 21695
Product ID: 21695-558_f3a50f13-b028-4135-8f20-bfb62a9bc0a9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clarithromycin
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp.
Application: ANDA065136
Marketing category: ANDA
Marketing start: 2005-08-25
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: E
Listing certified through: 2017-12-31
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	21695-558		I	Inactivated by FDA	2026-08-03
excluded package	package	21695-558	21695-558-10	I	Inactivated by FDA	2026-08-03
excluded package	package	21695-558	21695-558-14	I	Inactivated by FDA	2026-08-03
excluded package	package	21695-558	21695-558-20	I	Inactivated by FDA	2026-08-03
excluded package	package	21695-558	21695-558-28	I	Inactivated by FDA	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 2 · 110 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	21695-558		I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-558	21695-558-14	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-558	21695-558-28	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-558	21695-558-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-558	21695-558-20	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	21695-558		I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-558	21695-558-14	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-558	21695-558-28	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-558	21695-558-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-558	21695-558-20	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product	21695-558		I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-558	21695-558-14	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-558	21695-558-28	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-558	21695-558-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-558	21695-558-20	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	21695-558		I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-558	21695-558-14	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-558	21695-558-28	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-558	21695-558-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-558	21695-558-20	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	21695-558		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-558	21695-558-14	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-558	21695-558-28	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-558	21695-558-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-558	21695-558-20	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	21695-558		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-558	21695-558-14	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-558	21695-558-28	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-558	21695-558-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-558	21695-558-20	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	21695-558		I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-558	21695-558-14	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-558	21695-558-28	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-558	21695-558-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-558	21695-558-20	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	21695-558		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-558	21695-558-14	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-558	21695-558-28	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-558	21695-558-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-558	21695-558-20	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	21695-558		I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-558	21695-558-14	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-558	21695-558-28	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-558	21695-558-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-558	21695-558-20	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	21695-558		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-558	21695-558-14	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-558	21695-558-28	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-558	21695-558-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-558	21695-558-20	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	21695-558		I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-558	21695-558-14	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-558	21695-558-28	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-558	21695-558-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-558	21695-558-20	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	21695-558		I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-558	21695-558-14	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-558	21695-558-28	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-558	21695-558-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-558	21695-558-20	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065136-001	CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET / ORAL	AB		2005-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065136-001	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 2 · 41 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	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A065136-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065136-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065136-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065136-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065136-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065136-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065136-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065136-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065136-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065136-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065136-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065136-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065136-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065136-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065136-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065136-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065136-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065136-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065136-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065136-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065136-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065136-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065136-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065136-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065136-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065136-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065136-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065136-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065136-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065136-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065136-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065136-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065136-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065136-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065136-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065136-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065136-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065136-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065136-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065136-001	AB	1	`cb3db0bc1861…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clarithromycin	CLARITHROMYCIN	Northwind Health Company, LLC	f98aacb4-2f01-3e94-e053-6294a90a9aa0	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065136 application number: ANDA065136
Clarithromycin	CLARITHROMYCIN	PD-Rx Pharmaceuticals, Inc.	0be243c6-de02-45dd-8210-cab1bbc8dfa7	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065136 application number: ANDA065136
Clarithromycin	CLARITHROMYCIN	Coupler LLC	2d6cfd87-9b8c-bba9-e063-6294a90aff5a	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065136 application number: ANDA065136
Clarithromycin	CLARITHROMYCIN	DirectRx	d22bd12c-737b-4aab-e053-2995a90aff60	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065136 application number: ANDA065136
Clarithromycin	CLARITHROMYCIN	Bryant Ranch Prepack	27e02b77-4332-49e0-8d0c-a072cf5dff92	2024-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065136 application number: ANDA065136
Clarithromycin	CLARITHROMYCIN	Proficient Rx LP	28f60574-4ecd-441c-aebe-5b1d18033ef6	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065136 application number: ANDA065136
Clarithromycin	CLARITHROMYCIN	A-S Medication Solutions	adba78c2-9e51-4bed-8c6a-6f977f79c40c	2023-12-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065136 application number: ANDA065136
Clarithromycin	CLARITHROMYCIN	Sandoz Inc	b98b02bb-2609-49a0-b29f-e5911aa0cbc1	2023-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065136 application number: ANDA065136
Clarithromycin	CLARITHROMYCIN	Asclemed USA, Inc.	a12e4d38-e0f8-4467-a26c-bb25a342aa92	2020-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065136 application number: ANDA065136

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
21695-558-10	2019-09-24	C162847	48780-1	934fe258-4710-48b1-e053-8cdaa90a720a	Clarithromycin Tablets, USP
21695-558-14	2019-09-24	C162847	48780-1	934fe258-4710-48b1-e053-8cdaa90a720a	Clarithromycin Tablets, USP
21695-558-20	2019-09-24	C162847	48780-1	934fe258-4710-48b1-e053-8cdaa90a720a	Clarithromycin Tablets, USP
21695-558-28	2019-09-24	C162847	48780-1	934fe258-4710-48b1-e053-8cdaa90a720a	Clarithromycin Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-558-10	Clarithromycin	10 in 1 BOTTLE	TABLET	10	1
21695-558-14	Clarithromycin	14 in 1 BOTTLE	TABLET	14	1
21695-558-20	Clarithromycin	20 in 1 BOTTLE	TABLET	20	1
21695-558-28	Clarithromycin	28 in 1 BOTTLE	TABLET	28	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-558-10	EA - Each	21695-558	76faef6b-edd7-4693-b60b-5492196ddd33	1	2012-07-24
21695-558-14	EA - Each	21695-558	58b96e5e-048d-4931-8945-e13f084b30f0	1	2012-07-24
21695-558-20	EA - Each	21695-558	91ce61df-321d-4eea-ac39-6389211713ec	1	2012-07-24
21695-558-28	EA - Each	21695-558	6eb1a555-ce9d-403b-b57c-2c42d21984ad	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
clarithromycin	ACTIVE INGREDIENT	H1250JIK0A	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
clarithromycin	ACTIVE MOIETY	H1250JIK0A	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-558	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1	Legacy NDC, 4 package rows	20100921_f3a50f13-b028-4135-8f20-bfb62a9bc0a9.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	f3a50f13-b028-4135-8f20-bfb62a9bc0a9	1
197517	clarithromycin 500 MG Oral Tablet	PSN	f3a50f13-b028-4135-8f20-bfb62a9bc0a9	1
197516	clarithromycin 250 MG Oral Tablet	SCD	f3a50f13-b028-4135-8f20-bfb62a9bc0a9	1
197517	clarithromycin 500 MG Oral Tablet	SCD	f3a50f13-b028-4135-8f20-bfb62a9bc0a9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-558-10	21695055810	10 in 1 BOTTLE	Historical
21695-558-14	21695055814	14 in 1 BOTTLE	Historical
21695-558-20	21695055820	20 in 1 BOTTLE	Historical
21695-558-28	21695055828	28 in 1 BOTTLE	Historical