Clarithromycin

Product NDC: 50090-0994
11-digit product format: 500900994
Labeler code: 50090
Product ID: 50090-0994_b17c8e0b-5db9-4116-9073-8e8fac3459dc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clarithromycin
Dosage form: FOR SUSPENSION
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA065283
Marketing category: ANDA
Marketing start: 2007-09-04
Substance: CLARITHROMYCIN
Active strength: 250 mg/5mL
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: 2027-12-31
Current FDA listing: Yes

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
A065283-002	CLARITHROMYCIN	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04
A065283-003	CLARITHROMYCIN	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-09-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-09-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-09-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-09-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-09-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-09-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-09-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-09-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-09-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-09-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-09-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-09-04	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065283-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065283-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065283-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065283-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065283-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065283-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065283-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065283-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065283-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065283-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065283-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065283-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065283-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065283-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065283-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065283-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065283-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065283-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065283-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065283-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065283-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065283-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065283-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065283-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065283-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065283-003	AB	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	A065283-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A065283-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065283-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A065283-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065283-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065283-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065283-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A065283-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065283-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A065283-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065283-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065283-003	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clarithromycin	CLARITHROMYCIN	A-S Medication Solutions	fad1e5a3-59f9-4868-9937-d3b061ab8f00	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065283 application number: ANDA065283 ndc (product): 50090-0994
Clarithromycin	CLARITHROMYCIN	Sandoz Inc	22457862-0f88-4be8-b507-1c8f264269f2	2023-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065283 application number: ANDA065283

Additional Listing Data#

Finished product: Yes
Brand name base: Clarithromycin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLARITHROMYCIN	250 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
H1250JIK0A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309322	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fad1e5a3-59f9-4868-9937-d3b061ab8f00	Available on FDA.report

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
50090-0994-0	2023-02-07	C162847	48780-1	f386c649-ab14-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use CLARITHROMYCIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for CLARITHROMYCIN FOR ORAL SUSPENSION. CLARITHROMYCIN for oral suspension, for oral use Initial U.S. Approval: 1991
50090-0994-0	2023-01-30	C162847	48780-1	f386c649-ab14-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use CLARITHROMYCIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for CLARITHROMYCIN FOR ORAL SUSPENSION. CLARITHROMYCIN for oral suspension, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-0994-0	Clarithromycin	50 mL in 1 BOTTLE	FOR SUSPENSION	50		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0994-0	ML - Milliliter	50090-0994	18e3ad50-7de1-4f5c-883d-4e9c1484abee	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0994	CLARITHROMYCIN FOR SUSPENSION [A-S MEDICATION SOLUTIONS]	17	Current NDC, Legacy NDC, 1 package rows	20240113_fad1e5a3-59f9-4868-9937-d3b061ab8f00.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
309322	clarithromycin 250 MG in 5 mL Oral Suspension	PSN	fad1e5a3-59f9-4868-9937-d3b061ab8f00	19
309322	clarithromycin 50 MG/ML Oral Suspension	SCD	fad1e5a3-59f9-4868-9937-d3b061ab8f00	19
309322	clarithromycin 250 MG per 5 ML Oral Suspension	SY	fad1e5a3-59f9-4868-9937-d3b061ab8f00	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0994-0	50090099400	50 mL in 1 BOTTLE (50090-0994-0)	50 ml	2014-11-28	0000-00-00	No	No	Current