Clindacin PAC

Product NDC
43538-171
Requested package NDC
43538-171-69
11-digit product format
435380171
Labeler code
43538
Product ID
43538-171_84091640-aebc-46c5-87e7-330621609536
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clindamycin phosphate
Dosage form
SWAB
Route
TOPICAL
Labeler
Medimetriks Pharmaceuticals, Inc.
Application
ANDA065049
Marketing category
ANDA
Marketing start
2011-02-20
Marketing end
0000-00-00
Substance
CLINDAMYCIN PHOSPHATE
Active strength
10 mg/1
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage43538-17143538-171-69DDiscontinued by firm2026-08-03

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 1 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065049-001CLINDAMYCIN PHOSPHATECLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-25

Therapeutic equivalence codes#

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

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

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALAT2000-05-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALAT2000-05-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALAT2000-05-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALAT2000-05-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALAT2000-05-253f01610625f2…
2019-09-15 20:21 UTC2019-09A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALAT2000-05-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALAT2000-05-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065049-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALATRS2000-05-25cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065049-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065049-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065049-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065049-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065049-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065049-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065049-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065049-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065049-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065049-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065049-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065049-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065049-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065049-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065049-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065049-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065049-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065049-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065049-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065049-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065049-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A065049-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065049-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065049-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065049-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A065049-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065049-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065049-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065049-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065049-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065049-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065049-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065049-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065049-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065049-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065049-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065049-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065049-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065049-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065049-001AT1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d8f81258-db12-0761-46cc-8ff6e62e9302Product name420240422
b7b2fa42-1c77-d724-81f0-87da60a77e79Product name320240320
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
b27c7c65-51f2-a62f-e0e6-a26b3a0f8eb0Product name320230425
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
ffb4bacf-f636-0f7d-0b0d-7a4b151243e3Product name920220928
b72227d6-0388-43bd-995b-b762d2754cd5Product name120220706
a92d22e0-3af4-f301-bc88-27ff030b0070Product name220220316
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
5ce6ce33-4f2b-3ce0-757d-e520013280cfProduct name520180719
b92a26f1-6926-4817-be73-e26ab4c2146fProduct name120170602
028d6c95-5012-6976-2075-dee0ae6fefe2Product name120140508
468b2c08-8adb-8d0f-8257-c6515a061424Product name120140508
8959fb29-d86f-c521-666a-b4cb22233594Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43538-171-69Clindacin PAC1 in 1 KITSWAB15
43538-171-69Clindacin PAC69 in 1 JARSWAB695

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43538-171-69EA - Each43538-171db7a1402-add7-429a-8276-35290e223a2412012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43538-171CLINDACIN P (CLINDAMYCIN PHOSPHATE) SOLUTION CLINDACIN PAC (CLINDAMYCIN PHOSPHATE) SWAB [MEDIMETRIKS PHARMACEUTICALS, INC.]5Legacy NDC, 2 package rows20231116_288371ef-96b6-4ce3-9be1-1d9d309b400c.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clindacin PCLINDAMYCIN PHOSPHATEEurofarma, Inc.288371ef-96b6-4ce3-9be1-1d9d309b400c2026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065049
application number: ANDA065049
Clindacin ETZCLINDAMYCIN PHOSPHATEEurofarma, Inc.89fed26e-1cad-4c0b-8695-d6f3562ba8d52026-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065049
application number: ANDA065049
Clindamycin PhosphateCLINDAMYCIN PHOSPHATEPadagis Israel Pharmaceuticals Ltde492d645-7d2e-4f8a-a43a-9999456e9f722025-11-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065049
application number: ANDA065049
Clindamycin PhosphateCLINDAMYCIN PHOSPHATEA-S Medication Solutions9cf27a58-6c5f-4a02-88cc-b5ce3ecd87512024-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065049
application number: ANDA065049

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091339Clindacin Pledget 1 % Medicated PadPSN288371ef-96b6-4ce3-9be1-1d9d309b400c5
797274clindamycin 1 % Medicated PadPSN288371ef-96b6-4ce3-9be1-1d9d309b400c5
309333clindamycin phosphate 1 % Topical SolutionPSN288371ef-96b6-4ce3-9be1-1d9d309b400c5
1091339clindamycin 10 MG/ML Medicated Pad [Clindacin]SBD288371ef-96b6-4ce3-9be1-1d9d309b400c5
797274clindamycin 10 MG/ML Medicated PadSCD288371ef-96b6-4ce3-9be1-1d9d309b400c5
309333clindamycin 10 MG/ML Topical SolutionSCD288371ef-96b6-4ce3-9be1-1d9d309b400c5
1091339Clindacin 10 MG/ML Medicated PadSY288371ef-96b6-4ce3-9be1-1d9d309b400c5
1091339Clindacin ETZ (as clindamycin phosphate) 1 % Medicated PadSY288371ef-96b6-4ce3-9be1-1d9d309b400c5
1091339Clindacin P (as clindamycin phosphate) 1 % Medicated PadSY288371ef-96b6-4ce3-9be1-1d9d309b400c5
1091339Clindacin P 1 % Topical SwabSY288371ef-96b6-4ce3-9be1-1d9d309b400c5
309333clindamycin (as clindamycin phosphate) 1 % Topical SolutionSY288371ef-96b6-4ce3-9be1-1d9d309b400c5
797274clindamycin (as clindamycin phosphate) 10 MG/ML Medicated PadSY288371ef-96b6-4ce3-9be1-1d9d309b400c5
797274clindamycin 1 % Medicated PadSY288371ef-96b6-4ce3-9be1-1d9d309b400c5
309333clindamycin 1 % Topical SolutionSY288371ef-96b6-4ce3-9be1-1d9d309b400c5
797274clindamycin 1 % Topical SwabSY288371ef-96b6-4ce3-9be1-1d9d309b400c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43538-171-69435380171691 JAR in 1 KIT (43538-171-69) > 69 SWAB in 1 JAR1 jar2011-02-200000-00-00NoNoCurrent