Clarithromycin

Product NDC: 0054-0036
11-digit product format: 000540036
Labeler code: 0054
Product ID: 0054-0036_e3198f96-a449-4919-8856-b3753079d844
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clarithromycin
Dosage form: TABLET, COATED
Route: ORAL
Labeler: West-Ward Pharmaceuticals Corp.
Application: ANDA065178
Marketing category: ANDA
Marketing start: 2004-11-22
Marketing end: 2019-05-23
Substance: CLARITHROMYCIN
Active strength: 250 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: 0000-00-00
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	0054-0036		D	Discontinued by firm		2026-08-03
excluded package	package	0054-0036	0054-0036-21	D	Discontinued by firm		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 1 · 10 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	0054-0036		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0054-0036	0054-0036-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	0054-0036		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0054-0036	0054-0036-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	0054-0036		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0054-0036	0054-0036-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	0054-0036		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0054-0036	0054-0036-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	0054-0036		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0054-0036	0054-0036-21	D	Discontinued by firm	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065178-001	CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET / ORAL			2004-05-25
A065178-002	CLARITHROMYCIN	CLARITHROMYCIN	250MG	TABLET / ORAL			2004-05-25

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2004-05-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2004-05-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A065178-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065178-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A065178-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065178-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065178-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065178-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065178-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065178-002	AB	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0036-21	EA - Each	0054-0036	f7a6c602-0844-4d67-9648-0b6ccf4920d5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLARITHROMYCIN	ACTIVE INGREDIENT	H1250JIK0A	CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC]	13
CLARITHROMYCIN	ACTIVE MOIETY	H1250JIK0A	CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC]	13
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC]	13
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC]	13
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC]	13
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC]	13
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC]	13
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC]	13
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC]	13
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC]	13
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC]	13
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC]	13

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H1250JIK0A	CLARITHROMYCIN	81103-11-9	CLARITHROMYCIN

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clarithromycin	West-Ward Pharmaceuticals Corp. \| West-Ward Columbus Inc.	2019-09-23	HUMAN PRESCRIPTION DRUG LABEL	20