Clindamycin Hydrochloride

Product NDC
68788-6401
11-digit product format
687886401
Labeler code
68788
Product ID
68788-6401_2815c12f-5ec1-4f41-9844-1a158259d808
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA063029
Marketing category
ANDA
Marketing start
2016-06-01
Marketing end
0000-00-00
Substance
CLINDAMYCIN HYDROCHLORIDE
Active strength
300 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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-6401DDiscontinued by firm2026-08-03
excluded packagepackage68788-640168788-6401-1DDiscontinued by firm2026-08-03
excluded packagepackage68788-640168788-6401-2DDiscontinued by firm2026-08-03
excluded packagepackage68788-640168788-6401-3DDiscontinued by firm2026-08-03
excluded packagepackage68788-640168788-6401-4DDiscontinued by firm2026-08-03
excluded packagepackage68788-640168788-6401-5DDiscontinued by firm2026-08-03
excluded packagepackage68788-640168788-6401-6DDiscontinued by firm2026-08-03
excluded packagepackage68788-640168788-6401-8DDiscontinued 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 2 · 96 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-6401-8d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-6401-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-6401-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-6401-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-6401-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-6401-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-6401-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-6401-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-6401-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-6401-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-6401-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-6401-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-6401-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-6401-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-6401-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-6401-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-6401-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-6401-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-6401-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-6401-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-6401-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-6401-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-6401-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-6401-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-6401-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-6401-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-6401-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-6401-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-6401-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-6401-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-6401-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-6401-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-6401-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-6401-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-6401-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-6401-8cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-6401-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-6401-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-6401-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-6401-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-6401-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-6401-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-6401-8302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-6401-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-6401-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-6401-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-6401-4302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-6401-5302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-6401-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-6401-8ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-6401-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-6401-3ed331223b511…672a5bd82f5f…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A063029-001CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1989-09-20
A063029-002CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-05

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A063029-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1989-09-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A063029-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A063029-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1989-09-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A063029-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A063029-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1989-09-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A063029-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A063029-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1989-09-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A063029-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A063029-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1989-09-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A063029-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A063029-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1989-09-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A063029-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A063029-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1989-09-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A063029-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A063029-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1989-09-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A063029-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A063029-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1989-09-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A063029-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A063029-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1989-09-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A063029-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A063029-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1989-09-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A063029-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A063029-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1989-09-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A063029-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A063029-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1989-09-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A063029-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A063029-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1989-09-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A063029-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063029-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB1989-09-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063029-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2005-08-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A063029-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB1989-09-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A063029-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2005-08-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A063029-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB1989-09-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A063029-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2005-08-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A063029-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB1989-09-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A063029-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2005-08-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A063029-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB1989-09-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A063029-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2005-08-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A063029-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB1989-09-20782e0a99824c…
2021-12-28 21:50 UTC2021-12A063029-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2005-08-05782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063029-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063029-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A063029-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A063029-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A063029-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A063029-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A063029-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A063029-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A063029-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A063029-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A063029-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A063029-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A063029-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A063029-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A063029-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A063029-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A063029-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A063029-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A063029-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A063029-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A063029-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A063029-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A063029-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A063029-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A063029-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A063029-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A063029-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A063029-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A063029-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A063029-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A063029-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A063029-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A063029-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A063029-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A063029-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A063029-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A063029-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A063029-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A063029-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A063029-002AB13f0d92c62455…