Clindamycin hydrochloride

Product NDC
51655-964
11-digit product format
516550964
Labeler code
51655
Product ID
51655-964_4974b10e-b8ef-5aa8-e063-6294a90acd65
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA065061
Marketing category
ANDA
Marketing start
2023-03-13
Substance
CLINDAMYCIN HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 productproduct51655-964IInactivated by FDA2026-08-03
excluded packagepackage51655-96451655-964-52IInactivated 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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51655-964-52fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51655-964-5286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51655-964-52bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51655-964-528dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51655-964-52e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51655-964-529bebd1f3094a…5416666fcb17…

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
A065061-001CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2001-02-02
A065061-002CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2001-02-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065061-001AB
A065061-002AB

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 UTC2026-02A065061-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2001-02-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065061-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2001-02-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065061-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2001-02-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065061-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2001-02-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A065061-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2001-02-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065061-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2001-02-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065061-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2001-02-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065061-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2001-02-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065061-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2001-02-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065061-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2001-02-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065061-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2001-02-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065061-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2001-02-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065061-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2001-02-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065061-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2001-02-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065061-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2001-02-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065061-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2001-02-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065061-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2001-02-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065061-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2001-02-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065061-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2001-02-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A065061-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2001-02-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065061-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2001-02-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065061-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2001-02-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065061-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2001-02-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065061-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2001-02-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065061-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2001-02-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065061-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2001-02-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065061-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2001-02-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065061-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2001-02-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065061-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2001-02-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065061-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2001-02-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065061-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2001-02-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065061-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2001-02-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065061-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2001-02-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065061-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2001-02-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065061-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2001-02-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065061-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2001-02-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065061-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2001-02-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065061-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2001-02-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065061-001CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2001-02-02782e0a99824c…
2021-12-28 21:50 UTC2021-12A065061-002CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2001-02-02782e0a99824c…

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 UTC2026-02A065061-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065061-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065061-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065061-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065061-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065061-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065061-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065061-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065061-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065061-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065061-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065061-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065061-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065061-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065061-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065061-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065061-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065061-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065061-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065061-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065061-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065061-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065061-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065061-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065061-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065061-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065061-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065061-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065061-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065061-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065061-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065061-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065061-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065061-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065061-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065061-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065061-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065061-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065061-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065061-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Clindamycin hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN HYDROCHLORIDE150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
T20OQ1YN1WInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197518Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f781897a-ab54-7373-e053-6294a90a89a3Available on FDA.report

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-964-21Clindamycin hydrochloride21 in 1 BOTTLE, PLASTICCAPSULE215
51655-964-51Clindamycin hydrochloride40 in 1 BOTTLE, PLASTICCAPSULE405
51655-964-52Clindamycin hydrochloride30 in 1 BOTTLE, DISPENSINGCAPSULE304

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLINDAMYCIN HYDROCHLORIDEACTIVE INGREDIENTT20OQ1YN1WCLINDAMYCIN HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS]1
CLINDAMYCINACTIVE MOIETY3U02EL437CCLINDAMYCIN HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-964CLINDAMYCIN HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20241228_f781897a-ab54-7373-e053-6294a90a89a3.zip
51655-964CLINDAMYCIN HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 1 package rows20241228_6bc247ca-5101-4b6f-8cd8-00aab31c5798.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEHAWAII REPACK, INC.c6703df0-b41d-439f-8e0d-d30b3039b3f82026-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065061
application number: ANDA065061
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.fadc321a-2291-4268-936f-0743fdddbe7f2026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065061
application number: ANDA065061
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEMajor Pharmaceuticalsf9e6ed50-ad03-4a9e-8760-8733e04a058c2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065061
application number: ANDA065061
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.1dbd8448-c1e5-46df-8060-50ef823804452026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065061
application number: ANDA065061
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEUnit Dose Solutions, Inc.535e7e17-d020-4aa6-e063-6294a90ae1142026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065061
application number: ANDA065061
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEGolden State Medical Supply, Inc.a69260bb-31b5-4f77-e053-2995a90a37e12026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065061
application number: ANDA065061
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEREMEDYREPACK INC.7f7fc73a-86e1-4d3e-8c83-1c74621e4af42026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065061
application number: ANDA065061
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDECardinal Health 107, LLCb22be885-f441-473e-879a-862588dcf89d2026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065061
application number: ANDA065061
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDENorthwind Health Company, LLCf781897a-ab54-7373-e053-6294a90a89a32026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065061
application number: ANDA065061
ndc (product): 51655-964
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.4730ab20-09e2-d32a-e063-6394a90ae1252025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065061
application number: ANDA065061
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEAmerican Health Packaging3f6b2c5a-e581-414f-bc9e-eaf66a5685cd2025-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065061
application number: ANDA065061
Clindamycin HCLCLINDAMYCIN HCLAdvanced Rx of Tennessee, LLCb43dc396-17ef-a523-e053-2a95a90ac8722024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065061
application number: ANDA065061
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepack2b13d66d-4f48-477e-ba32-20e85d0e708d2024-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065061
application number: ANDA065061
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepack7537fbab-c792-4b77-8736-c24b69cf48ea2024-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065061
application number: ANDA065061
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.678912ff-a0c1-171b-e053-2991aa0ad1282024-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065061
application number: ANDA065061
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.63f26644-b7ab-98c1-e053-2a91aa0af5d32024-06-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065061
application number: ANDA065061
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions337870c6-11e0-4d1a-a26e-afe042ee08c32024-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065061
application number: ANDA065061
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions600c5ac7-64f7-44ac-9e83-cc1036471eec2023-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065061
application number: ANDA065061
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions22bf9385-cad3-43a7-802f-131b6826b5a52023-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065061
application number: ANDA065061
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEAsclemed USA, Inc.cd5a1db8-9ddf-4de3-b856-bc3e8fb290612023-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065061
application number: ANDA065061

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSNf781897a-ab54-7373-e053-6294a90a89a35
197518clindamycin 150 MG Oral CapsuleSCDf781897a-ab54-7373-e053-6294a90a89a35
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSYf781897a-ab54-7373-e053-6294a90a89a35
197518clindamycin HCl 150 MG Oral CapsulePSN6bc247ca-5101-4b6f-8cd8-00aab31c57984
197518clindamycin 150 MG Oral CapsuleSCD6bc247ca-5101-4b6f-8cd8-00aab31c57984
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY6bc247ca-5101-4b6f-8cd8-00aab31c57984

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-964-215165509642121 CAPSULE in 1 BOTTLE, PLASTIC (51655-964-21) 21 capsule2023-03-13NoNoCurrent
51655-964-515165509645140 CAPSULE in 1 BOTTLE, PLASTIC (51655-964-51) 40 capsule2024-06-04NoNoCurrent
51655-964-525165509645230 in 1 BOTTLE, DISPENSINGHistorical