Clindacin ETZ

Product NDC: 43538-173
Requested package NDC: 43538-173-60
11-digit product format: 435380173
Labeler code: 43538
Product ID: 43538-173_fd6c8795-7331-42d6-8a8b-95f9e964b9ee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clindamycin phosphate
Dosage form: KIT
Labeler: Medimetriks Pharmaceuticals, Inc.
Application: ANDA065049
Marketing category: ANDA
Marketing start: 2013-06-15
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	43538-173	43538-173-60	D	Discontinued by firm		2026-08-03

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
A065049-001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065049-001	AT

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT		2000-05-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT		2000-05-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT		2000-05-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT		2000-05-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT		2000-05-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT		2000-05-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT		2000-05-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`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	A065049-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065049-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065049-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065049-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065049-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065049-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065049-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065049-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065049-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065049-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065049-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065049-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065049-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065049-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065049-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065049-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065049-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065049-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065049-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065049-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065049-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065049-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065049-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065049-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065049-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065049-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065049-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065049-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065049-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065049-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065049-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065049-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065049-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065049-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065049-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065049-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065049-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065049-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065049-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065049-001	AT	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43538-173-60	EA - Each	43538-173	2d4d7e1d-f814-41c7-8507-b85180e6fb5d	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
clindamycin phosphate	ACTIVE INGREDIENT	EH6D7113I8	CLINDACIN ETZ (CLINDAMYCIN PHOSPHATE) SWAB CLINDACIN ETZ (CLINDAMYCIN PHOSPHATE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]	1
clindamycin	ACTIVE MOIETY	3U02EL437C	CLINDACIN ETZ (CLINDAMYCIN PHOSPHATE) SWAB CLINDACIN ETZ (CLINDAMYCIN PHOSPHATE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]	1
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	CLINDACIN ETZ (CLINDAMYCIN PHOSPHATE) SWAB CLINDACIN ETZ (CLINDAMYCIN PHOSPHATE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	CLINDACIN ETZ (CLINDAMYCIN PHOSPHATE) SWAB CLINDACIN ETZ (CLINDAMYCIN PHOSPHATE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	CLINDACIN ETZ (CLINDAMYCIN PHOSPHATE) SWAB CLINDACIN ETZ (CLINDAMYCIN PHOSPHATE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	CLINDACIN ETZ (CLINDAMYCIN PHOSPHATE) SWAB CLINDACIN ETZ (CLINDAMYCIN PHOSPHATE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43538-173	CLINDACIN ETZ (CLINDAMYCIN PHOSPHATE) SWAB CLINDACIN ETZ (CLINDAMYCIN PHOSPHATE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]	5	Legacy NDC	20241215_89fed26e-1cad-4c0b-8695-d6f3562ba8d5.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindacin P	CLINDAMYCIN PHOSPHATE	Eurofarma, Inc.	288371ef-96b6-4ce3-9be1-1d9d309b400c	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065049 application number: ANDA065049
Clindacin ETZ	CLINDAMYCIN PHOSPHATE	Eurofarma, Inc.	89fed26e-1cad-4c0b-8695-d6f3562ba8d5	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065049 application number: ANDA065049
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Padagis Israel Pharmaceuticals Ltd	e492d645-7d2e-4f8a-a43a-9999456e9f72	2025-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065049 application number: ANDA065049
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	A-S Medication Solutions	9cf27a58-6c5f-4a02-88cc-b5ce3ecd8751	2024-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065049 application number: ANDA065049

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EH6D7113I8	CLINDAMYCIN PHOSPHATE	24729-96-2	clindamycin phosphate

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43538-173-60	43538017360	1 KIT in 1 CARTON (43538-173-60) * 473 mL in 1 BOTTLE * 60 SWAB in 1 CARTON	1 kit	2013-06-15	0000-00-00	No	No	Current