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#

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	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#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 2 · 75 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
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…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product	21695-558		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-558	21695-558-14	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-558	21695-558-28	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-558	21695-558-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-558	21695-558-20	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product	21695-558		I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-558	21695-558-14	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-558	21695-558-28	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-558	21695-558-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-558	21695-558-20	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	21695-558		I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-558	21695-558-14	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-558	21695-558-28	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-558	21695-558-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-558	21695-558-20	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	21695-558		I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-558	21695-558-14	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-558	21695-558-28	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-558	21695-558-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-558	21695-558-20	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product	21695-558		I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-558	21695-558-14	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-558	21695-558-28	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-558	21695-558-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-558	21695-558-20	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product	21695-558		I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-558	21695-558-14	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-558	21695-558-28	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-558	21695-558-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-558	21695-558-20	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product	21695-558		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-558	21695-558-14	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-558	21695-558-28	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-558	21695-558-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-558	21695-558-20	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`

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#

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 · 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