CLINDAMYCIN HYDROCHLORIDE

Product NDC
61919-310
11-digit product format
619190310
Labeler code
61919
Product ID
61919-310_9c9341dc-c330-9189-e053-2995a90a4c1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLINDAMYCIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA063083
Marketing category
ANDA
Marketing start
2018-03-26
Marketing end
0000-00-00
Substance
CLINDAMYCIN HYDROCHLORIDE
Active strength
150 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-310IInactivated by FDA2026-08-03
excluded packagepackage61919-31061919-310-30IInactivated 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 · 30 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 packagepackage61919-310-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-310-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-310-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-310-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-310-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-310-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-310-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-310-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-310-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-310-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-310-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-310-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-310-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-310-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-310-301332a3947898…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
A063083-001CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1991-07-31
A063083-002CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2003-03-18

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 UTC2026-02A063083-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1991-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A063083-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2003-03-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A063083-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1991-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A063083-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2003-03-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A063083-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1991-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A063083-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2003-03-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A063083-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1991-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A063083-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2003-03-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A063083-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1991-07-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A063083-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2003-03-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A063083-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1991-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A063083-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2003-03-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A063083-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1991-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A063083-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2003-03-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A063083-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1991-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A063083-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2003-03-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A063083-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1991-07-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A063083-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2003-03-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A063083-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1991-07-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A063083-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2003-03-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A063083-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1991-07-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A063083-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2003-03-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A063083-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1991-07-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A063083-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2003-03-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A063083-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1991-07-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A063083-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2003-03-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A063083-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL1991-07-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A063083-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2003-03-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063083-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB1991-07-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063083-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2003-03-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A063083-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB1991-07-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A063083-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2003-03-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A063083-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB1991-07-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A063083-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2003-03-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A063083-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB1991-07-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A063083-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2003-03-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A063083-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB1991-07-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A063083-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2003-03-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A063083-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB1991-07-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A063083-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2003-03-18782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063083-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063083-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A063083-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A063083-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A063083-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A063083-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A063083-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A063083-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A063083-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A063083-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A063083-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A063083-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A063083-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A063083-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A063083-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A063083-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A063083-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A063083-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A063083-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A063083-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A063083-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A063083-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A063083-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A063083-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A063083-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A063083-002AB1ea99ee380514…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A063083-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A063083-002AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A063083-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A063083-002AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A063083-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A063083-002AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A063083-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A063083-002AB1cb3db0bc1861…

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
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-310-302023-01-30C16284748780-1f386c649-f390-0266-e053-dadaa90a7c1aCLINDAMYCIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-310-30CLINDAMYCIN HYDROCHLORIDE30 in 1 BOTTLECAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-310-30EA - Each61919-31017eda4d2-1c91-458c-8d94-c8a183941c2412018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-310CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2Legacy NDC, 1 package rows20200121_685230d0-5596-5867-e053-2991aa0a2366.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSN685230d0-5596-5867-e053-2991aa0a23662
197518clindamycin 150 MG Oral CapsuleSCD685230d0-5596-5867-e053-2991aa0a23662
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY685230d0-5596-5867-e053-2991aa0a23662

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-310-306191903103030 CAPSULE in 1 BOTTLE (61919-310-30) 30 capsule2018-03-260000-00-00NoNoCurrent