FDA.reportPublic FDA data

CLINDAMYCIN HYDROCHLORIDE

Product NDC
42571-252
11-digit product format
425710252
Labeler code
42571
Product ID
42571-252_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
300 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 HYDROCHLORIDE300 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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
42571-252-01CLINDAMYCIN HYDROCHLORIDE100 in 1 BOTTLECAPSULE10013
42571-252-05CLINDAMYCIN HYDROCHLORIDE500 in 1 BOTTLECAPSULE50013
42571-252-10CLINDAMYCIN HYDROCHLORIDE1000 in 1 BOTTLECAPSULE100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-252-01EA - Each42571-252ab2ff62d-3410-4b4a-9445-55ffcf27f9d112019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-252CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [MICRO LABS LIMITED]10Current NDC, Legacy NDC, 3 package rows20250515_9b9f898f-6a91-44f8-9508-f9ddfaad27bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284215clindamycin HCl 300 MG Oral CapsulePSNf4c4fce0-0472-45a3-b4c6-192d97ca181821
284215clindamycin 300 MG Oral CapsuleSCDf4c4fce0-0472-45a3-b4c6-192d97ca181821
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSYf4c4fce0-0472-45a3-b4c6-192d97ca181821
284215clindamycin HCl 300 MG Oral CapsulePSN8e3c9cf6-ab39-4fb5-94e3-232880c4770016
284215clindamycin 300 MG Oral CapsuleSCD8e3c9cf6-ab39-4fb5-94e3-232880c4770016
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY8e3c9cf6-ab39-4fb5-94e3-232880c4770016
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
284215clindamycin HCl 300 MG Oral CapsulePSNbea7de4c-c077-4535-96a0-f6b319120b0b11
284215clindamycin 300 MG Oral CapsuleSCDbea7de4c-c077-4535-96a0-f6b319120b0b11
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSYbea7de4c-c077-4535-96a0-f6b319120b0b11
284215clindamycin HCl 300 MG Oral CapsulePSN07f5d841-9c58-4dd1-b0bc-e12553931c8e8
284215clindamycin 300 MG Oral CapsuleSCD07f5d841-9c58-4dd1-b0bc-e12553931c8e8
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY07f5d841-9c58-4dd1-b0bc-e12553931c8e8
284215clindamycin HCl 300 MG Oral CapsulePSN1d562ae9-5a9a-4fed-8cc7-3f30fb40f9577
284215clindamycin 300 MG Oral CapsuleSCD1d562ae9-5a9a-4fed-8cc7-3f30fb40f9577
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY1d562ae9-5a9a-4fed-8cc7-3f30fb40f9577
284215clindamycin HCl 300 MG Oral CapsulePSNa2f6fa76-a114-4104-e053-2a95a90a9e0b6
284215clindamycin 300 MG Oral CapsuleSCDa2f6fa76-a114-4104-e053-2a95a90a9e0b6
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSYa2f6fa76-a114-4104-e053-2a95a90a9e0b6
284215clindamycin HCl 300 MG Oral CapsulePSNf7e51a42-bc9e-490f-b8d8-8765f0b5be465
284215clindamycin HCl 300 MG Oral CapsulePSNc3f35f80-e4ae-95f5-e053-2995a90a1b645
284215clindamycin 300 MG Oral CapsuleSCDc3f35f80-e4ae-95f5-e053-2995a90a1b645
284215clindamycin 300 MG Oral CapsuleSCDf7e51a42-bc9e-490f-b8d8-8765f0b5be465
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSYc3f35f80-e4ae-95f5-e053-2995a90a1b645
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSYf7e51a42-bc9e-490f-b8d8-8765f0b5be465
284215clindamycin HCl 300 MG Oral CapsulePSNba9bd5cd-036b-4b0c-e053-2a95a90a332e3
284215clindamycin HCl 300 MG Oral CapsulePSNb2a810f1-c009-e973-e053-2a95a90ad5b03
284215clindamycin HCl 300 MG Oral CapsulePSN9e68cb17-73d9-8a00-e053-2995a90a517f3
284215clindamycin 300 MG Oral CapsuleSCDb2a810f1-c009-e973-e053-2a95a90ad5b03
284215clindamycin 300 MG Oral CapsuleSCDba9bd5cd-036b-4b0c-e053-2a95a90a332e3
284215clindamycin 300 MG Oral CapsuleSCD9e68cb17-73d9-8a00-e053-2995a90a517f3
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSYb2a810f1-c009-e973-e053-2a95a90ad5b03
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSYba9bd5cd-036b-4b0c-e053-2a95a90a332e3
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY9e68cb17-73d9-8a00-e053-2995a90a517f3
197518clindamycin HCl 150 MG Oral CapsulePSN7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721
284215clindamycin HCl 300 MG Oral CapsulePSN88e5aedb-4d84-4fda-9bc1-05f0ed12279d1
284215clindamycin HCl 300 MG Oral CapsulePSN7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721
284215clindamycin HCl 300 MG Oral CapsulePSN1d760cb7-d166-6707-e063-6394a90a88501
284215clindamycin HCl 300 MG Oral CapsulePSNcd2ca915-5672-440d-a14e-b4d3b6a522f31
309329clindamycin HCl 75 MG Oral CapsulePSN7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721
197518clindamycin 150 MG Oral CapsuleSCD7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721
284215clindamycin 300 MG Oral CapsuleSCD88e5aedb-4d84-4fda-9bc1-05f0ed12279d1
284215clindamycin 300 MG Oral CapsuleSCDcd2ca915-5672-440d-a14e-b4d3b6a522f31
284215clindamycin 300 MG Oral CapsuleSCD7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721
284215clindamycin 300 MG Oral CapsuleSCD1d760cb7-d166-6707-e063-6394a90a88501
309329clindamycin 75 MG Oral CapsuleSCD7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSYcd2ca915-5672-440d-a14e-b4d3b6a522f31
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY7d3e6ec5-93e9-4ce0-8276-b19aa97eb7721
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY1d760cb7-d166-6707-e063-6394a90a88501
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY88e5aedb-4d84-4fda-9bc1-05f0ed12279d1
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
42571-252-0142571025201100 CAPSULE in 1 BOTTLE (42571-252-01) 100 capsule2019-01-070000-00-00NoNoCurrent
42571-252-0542571025205500 CAPSULE in 1 BOTTLE (42571-252-05) 500 capsule2019-01-070000-00-00NoNoCurrent
42571-252-10425710252101000 CAPSULE in 1 BOTTLE (42571-252-10) 1000 capsule2019-01-070000-00-00NoNoCurrent