FDA.reportPublic FDA data

CLINDAMYCIN HYDROCHLORIDE

Product NDC
42571-251
11-digit product format
425710251
Labeler code
42571
Product ID
42571-251_4e518230-035d-d99a-e063-6394a90af9cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA207402
Marketing category
ANDA
Marketing start
2019-01-07
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

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 Identifiers#

Field, Values table
FieldValues
UniiT20OQ1YN1W
Rxcui197518, 284215, 309329

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42571-251-01CLINDAMYCIN HYDROCHLORIDE100 in 1 BOTTLECAPSULE10013
42571-251-05CLINDAMYCIN HYDROCHLORIDE500 in 1 BOTTLECAPSULE50013
42571-251-10CLINDAMYCIN HYDROCHLORIDE1000 in 1 BOTTLECAPSULE100013
42571-251-23CLINDAMYCIN HYDROCHLORIDE80 in 1 CARTONCAPSULE8013
42571-251-32CLINDAMYCIN HYDROCHLORIDE10 in 1 BLISTER PACKCAPSULE1013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-251-01EA - Each42571-2513e06eb11-4d14-4b79-9ca2-722af7b2a11512019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-251CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [MICRO LABS LIMITED]10Current NDC, Legacy NDC, 5 package rows20250515_9b9f898f-6a91-44f8-9508-f9ddfaad27bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSN5f6a85c5-dca3-49b1-a029-3818a41d49bf104
197518clindamycin 150 MG Oral CapsuleSCD5f6a85c5-dca3-49b1-a029-3818a41d49bf104
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY5f6a85c5-dca3-49b1-a029-3818a41d49bf104
197518clindamycin HCl 150 MG Oral CapsulePSNde7001d1-8b83-4f8b-8e50-c0769102145621
197518clindamycin 150 MG Oral CapsuleSCDde7001d1-8b83-4f8b-8e50-c0769102145621
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSYde7001d1-8b83-4f8b-8e50-c0769102145621
197518clindamycin HCl 150 MG Oral CapsulePSN9b9f898f-6a91-44f8-9508-f9ddfaad27bc13
284215clindamycin HCl 300 MG Oral CapsulePSN9b9f898f-6a91-44f8-9508-f9ddfaad27bc13
309329clindamycin HCl 75 MG Oral CapsulePSN9b9f898f-6a91-44f8-9508-f9ddfaad27bc13
197518clindamycin 150 MG Oral CapsuleSCD9b9f898f-6a91-44f8-9508-f9ddfaad27bc13
284215clindamycin 300 MG Oral CapsuleSCD9b9f898f-6a91-44f8-9508-f9ddfaad27bc13
309329clindamycin 75 MG Oral CapsuleSCD9b9f898f-6a91-44f8-9508-f9ddfaad27bc13
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY9b9f898f-6a91-44f8-9508-f9ddfaad27bc13
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY9b9f898f-6a91-44f8-9508-f9ddfaad27bc13
309329clindamycin (as clindamycin hydrochloride) 75 MG Oral CapsuleSY9b9f898f-6a91-44f8-9508-f9ddfaad27bc13
197518clindamycin HCl 150 MG Oral CapsulePSN9fe44bdd-eb59-4b55-e053-2995a90a31836
197518clindamycin HCl 150 MG Oral CapsulePSN18ef4551-4066-4765-90cb-285d7711cf616
197518clindamycin 150 MG Oral CapsuleSCD18ef4551-4066-4765-90cb-285d7711cf616
197518clindamycin 150 MG Oral CapsuleSCD9fe44bdd-eb59-4b55-e053-2995a90a31836
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY18ef4551-4066-4765-90cb-285d7711cf616
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY9fe44bdd-eb59-4b55-e053-2995a90a31836
197518clindamycin HCl 150 MG Oral CapsulePSN96b42773-dca4-7e6e-e053-2995a90a49a95
197518clindamycin 150 MG Oral CapsuleSCD96b42773-dca4-7e6e-e053-2995a90a49a95
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY96b42773-dca4-7e6e-e053-2995a90a49a95
197518clindamycin HCl 150 MG Oral CapsulePSNf6f5c8b2-83a1-5362-e053-6394a90aaaad4
197518clindamycin 150 MG Oral CapsuleSCDf6f5c8b2-83a1-5362-e053-6394a90aaaad4
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSYf6f5c8b2-83a1-5362-e053-6394a90aaaad4
197518clindamycin HCl 150 MG Oral CapsulePSNbde81d4b-ad21-cc09-e053-2995a90a8c013
197518clindamycin HCl 150 MG Oral CapsulePSNafeb96ed-7c2e-72d3-e053-2995a90a4ed33
197518clindamycin HCl 150 MG Oral CapsulePSNb2bd8402-c887-5bfd-e053-2a95a90a15d93
197518clindamycin 150 MG Oral CapsuleSCDbde81d4b-ad21-cc09-e053-2995a90a8c013
197518clindamycin 150 MG Oral CapsuleSCDb2bd8402-c887-5bfd-e053-2a95a90a15d93
197518clindamycin 150 MG Oral CapsuleSCDafeb96ed-7c2e-72d3-e053-2995a90a4ed33
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSYbde81d4b-ad21-cc09-e053-2995a90a8c013
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSYafeb96ed-7c2e-72d3-e053-2995a90a4ed33
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSYb2bd8402-c887-5bfd-e053-2a95a90a15d93
197518clindamycin HCl 150 MG Oral CapsulePSNde7ff699-528a-4f62-b511-f004aec8dc791
197518clindamycin HCl 150 MG Oral CapsulePSN7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721
197518clindamycin HCl 150 MG Oral CapsulePSN26b91118-5250-8fc5-e063-6394a90a99bd1
284215clindamycin HCl 300 MG Oral CapsulePSN7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721
309329clindamycin HCl 75 MG Oral CapsulePSN7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721
197518clindamycin 150 MG Oral CapsuleSCD26b91118-5250-8fc5-e063-6394a90a99bd1
197518clindamycin 150 MG Oral CapsuleSCDde7ff699-528a-4f62-b511-f004aec8dc791
197518clindamycin 150 MG Oral CapsuleSCD7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721
284215clindamycin 300 MG Oral CapsuleSCD7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721
309329clindamycin 75 MG Oral CapsuleSCD7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY26b91118-5250-8fc5-e063-6394a90a99bd1
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSYde7ff699-528a-4f62-b511-f004aec8dc791
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721
309329clindamycin (as clindamycin hydrochloride) 75 MG Oral CapsuleSY7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-251-0142571025101100 CAPSULE in 1 BOTTLE (42571-251-01) 100 capsule2019-01-070000-00-00NoNoCurrent
42571-251-0542571025105500 CAPSULE in 1 BOTTLE (42571-251-05) 500 capsule2019-01-070000-00-00NoNoCurrent
42571-251-10425710251101000 CAPSULE in 1 BOTTLE (42571-251-10) 1000 capsule2019-01-070000-00-00NoNoCurrent
42571-251-234257102512380 BLISTER PACK in 1 CARTON (42571-251-23) / 10 CAPSULE in 1 BLISTER PACK (42571-251-32) 80 blister pack2019-01-070000-00-00NoNoCurrent
42571-251-324257102513210 in 1 BLISTER PACKHistorical