Clindamycin Hydrochloride

Product NDC
50090-3242
Requested package NDC
50090-3242-1
11-digit product format
500903242
Labeler code
50090
Product ID
50090-3242_cfd499a8-f957-482a-a5c6-1b57935f136c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA063029
Marketing category
ANDA
Marketing start
2016-03-14
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
2021-12-31
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 packagepackage50090-324250090-3242-1IInactivated by FDA2026-08-03

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 · 15 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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…

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
b27c7c65-51f2-a62f-e0e6-a26b3a0f8eb0Product name320230425
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3242-0Clindamycin Hydrochloride30 in 1 BOTTLECAPSULE303
50090-3242-1Clindamycin Hydrochloride45 in 1 BOTTLECAPSULE453
50090-3242-2Clindamycin Hydrochloride16 in 1 BOTTLECAPSULE163
50090-3242-3Clindamycin Hydrochloride40 in 1 BOTTLECAPSULE403
50090-3242-4Clindamycin Hydrochloride20 in 1 BOTTLECAPSULE203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3242-0EA - Each50090-3242d6c3ed37-66f5-4b95-a8d4-1b692325e87312019-05-02
50090-3242-1EA - Each50090-3242b54a1199-0d43-4e43-a8f0-ac6855bb0c3312020-02-13
50090-3242-2EA - Each50090-324221db8ca7-833c-4426-9aaf-26582595dc8412020-02-13
50090-3242-3EA - Each50090-32426533b6d1-333d-4943-8249-2fa711ec5aed12020-02-13
50090-3242-4EA - Each50090-324216bfb58b-405c-491d-bbe0-be8f399747c212020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3242CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [A-S MEDICATION SOLUTIONS]3Legacy NDC, 5 package rows20200122_b6ff9d4b-a478-4856-a516-1454e1f81a5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284215clindamycin HCl 300 MG Oral CapsulePSNb6ff9d4b-a478-4856-a516-1454e1f81a5e3
284215clindamycin 300 MG Oral CapsuleSCDb6ff9d4b-a478-4856-a516-1454e1f81a5e3
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSYb6ff9d4b-a478-4856-a516-1454e1f81a5e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3242-15009032420145 CAPSULE in 1 BOTTLE (50090-3242-1) 45 capsule2018-02-020000-00-00NoNoCurrent