Clindamycin Hydrochloride

Product NDC
50090-4317
11-digit product format
500904317
Labeler code
50090
Product ID
50090-4317_8f818fc4-3150-4afd-81f0-4b5f928c649e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065442
Marketing category
ANDA
Marketing start
2009-08-26
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-4317IInactivated by FDA2026-08-03
excluded packagepackage50090-431750090-4317-0IInactivated by FDA2026-08-03
excluded packagepackage50090-431750090-4317-1IInactivated 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 · 45 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 packagepackage50090-4317-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-4317-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-4317-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-4317-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-4317-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-4317-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-4317-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-4317-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-4317-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-4317-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-4317-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-4317-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-4317-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-4317-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-4317-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-4317-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-4317-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-4317-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-4317-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-4317-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-4317-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-4317-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-4317-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-4317-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-4317-18af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-4317-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-4317-1834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-4317-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-4317-11332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-4317-01332a3947898…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
A065442-001CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2009-08-26
A065442-002CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2009-08-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A065442-001AB
A065442-002AB

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 UTC2026-02A065442-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2009-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065442-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2009-08-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065442-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2009-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065442-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2009-08-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A065442-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2009-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065442-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2009-08-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065442-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2009-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065442-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2009-08-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065442-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2009-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065442-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2009-08-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065442-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2009-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065442-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2009-08-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065442-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2009-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065442-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2009-08-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065442-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2009-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065442-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2009-08-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065442-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2009-08-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065442-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2009-08-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065442-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2009-08-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A065442-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2009-08-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065442-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2009-08-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065442-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2009-08-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065442-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2009-08-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065442-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2009-08-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065442-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2009-08-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065442-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2009-08-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065442-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2009-08-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065442-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2009-08-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065442-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2009-08-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065442-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2009-08-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065442-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2009-08-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065442-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2009-08-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065442-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2009-08-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065442-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2009-08-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065442-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2009-08-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065442-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2009-08-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065442-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2009-08-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065442-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2009-08-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065442-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2009-08-26782e0a99824c…
2021-12-28 21:50 UTC2021-12A065442-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2009-08-26782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065442-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065442-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065442-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065442-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065442-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065442-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065442-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065442-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065442-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065442-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065442-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065442-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065442-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065442-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065442-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065442-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065442-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065442-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065442-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065442-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065442-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065442-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065442-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065442-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065442-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065442-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065442-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065442-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065442-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065442-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065442-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065442-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065442-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065442-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065442-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065442-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065442-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065442-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065442-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065442-002AB1782e0a99824c…

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
50090-4317-02023-01-30C16284748780-1f386c64a-166d-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP Rx only
50090-4317-12023-01-30C16284748780-1f386c64a-166d-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4317-0Clindamycin Hydrochloride30 in 1 BOTTLECAPSULE302
50090-4317-1Clindamycin Hydrochloride30 in 1 BOTTLECAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4317CLINDAMYCIN HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]2Legacy NDC, 2 package rows20190605_11aa9f41-9ebf-460c-925d-debea47e2450.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEMajor Pharmaceuticalsd53a66bf-fdbd-4a12-8d8c-4e3ab94e9ef52026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065442
application number: ANDA065442
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEAurobindo Pharma Limited2367340c-d297-4a3f-8253-6d27a0ed39cb2026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065442
application number: ANDA065442
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDENorthwind Health Company, LLCf2f08e98-f6c5-7c2d-e053-2995a90abe1e2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065442
application number: ANDA065442
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDERedpharm Drug0a0fbeae-2bc2-2402-e063-6394a90a97a02025-12-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065442
application number: ANDA065442
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEVERITYRX, LLC427a0138-c2dd-cf0b-e063-6394a90af4072025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065442
application number: ANDA065442
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions9fe68a5a-487b-4119-9ee7-603948d732e42025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065442
application number: ANDA065442
Clindamycin HCLCLINDAMYCIN HCLAdvanced Rx Pharmacy of Tennessee, LLCc46cac0a-0c36-02fa-e053-2995a90a772b2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065442
application number: ANDA065442
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions8af1493c-1f22-4629-a432-f8b0578189e12024-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065442
application number: ANDA065442
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions2393251d-33b9-4274-9d04-27ec9968eaa12024-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065442
application number: ANDA065442
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEProficient Rx LPd6e1a5f2-9dcb-49fb-a5b0-d7d543520ac32022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065442
application number: ANDA065442

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284215clindamycin HCl 300 MG Oral CapsulePSN11aa9f41-9ebf-460c-925d-debea47e24502
284215clindamycin 300 MG Oral CapsuleSCD11aa9f41-9ebf-460c-925d-debea47e24502
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY11aa9f41-9ebf-460c-925d-debea47e24502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4317-05009043170030 CAPSULE in 1 BOTTLE (50090-4317-0) 30 capsule2019-05-290000-00-00NoNoCurrent
50090-4317-15009043170130 CAPSULE in 1 BOTTLE (50090-4317-1) 30 capsule2019-05-290000-00-00NoNoCurrent