FDA.reportPublic FDA data

Clindamycin Hydrochloride

Product NDC
68462-143
11-digit product format
684620143
Labeler code
68462
Product ID
68462-143_1420c437-e47e-4757-9b4c-3c8ad8a936bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
GLENMARK PHARMACEUTICALS INC., USA
Application
ANDA216957
Marketing category
ANDA
Marketing start
2023-03-10
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
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
68462-143-01Clindamycin Hydrochloride100 in 1 BOTTLECAPSULE1004
68462-143-05Clindamycin Hydrochloride500 in 1 BOTTLECAPSULE5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-143-01EA - Each68462-143e947e643-1f81-40d5-a810-8943f5fdfea412023-06-06
68462-143-05EA - Each68462-14348dc7d19-7a36-4b2c-af5a-3af095f909d912023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-143CLINDAMYCIN HYDROCHLORIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]2Current NDC, 2 package rows20240907_8e66de7a-d9d4-4562-bc99-80489d482da4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSNebdcd3ce-3140-4bf6-b8b8-468ead08d9a96
197518clindamycin 150 MG Oral CapsuleSCDebdcd3ce-3140-4bf6-b8b8-468ead08d9a96
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSYebdcd3ce-3140-4bf6-b8b8-468ead08d9a96
197518clindamycin HCl 150 MG Oral CapsulePSN12dea490-e179-f295-e063-6394a90af4aa5
197518clindamycin 150 MG Oral CapsuleSCD12dea490-e179-f295-e063-6394a90af4aa5
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY12dea490-e179-f295-e063-6394a90af4aa5
197518clindamycin HCl 150 MG Oral CapsulePSN8e66de7a-d9d4-4562-bc99-80489d482da44
284215clindamycin HCl 300 MG Oral CapsulePSN8e66de7a-d9d4-4562-bc99-80489d482da44
309329clindamycin HCl 75 MG Oral CapsulePSN8e66de7a-d9d4-4562-bc99-80489d482da44
197518clindamycin 150 MG Oral CapsuleSCD8e66de7a-d9d4-4562-bc99-80489d482da44
284215clindamycin 300 MG Oral CapsuleSCD8e66de7a-d9d4-4562-bc99-80489d482da44
309329clindamycin 75 MG Oral CapsuleSCD8e66de7a-d9d4-4562-bc99-80489d482da44
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY8e66de7a-d9d4-4562-bc99-80489d482da44
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY8e66de7a-d9d4-4562-bc99-80489d482da44
309329clindamycin (as clindamycin hydrochloride) 75 MG Oral CapsuleSY8e66de7a-d9d4-4562-bc99-80489d482da44
197518clindamycin HCl 150 MG Oral CapsulePSN1f1b9230-b8ef-b0e4-e063-6394a90afc473
197518clindamycin HCl 150 MG Oral CapsulePSN2178249b-a9fe-5015-e063-6294a90a9ff43
197518clindamycin HCl 150 MG Oral CapsulePSN51dfa3fa-6f6a-4904-a8d3-b5938cf9c8523
197518clindamycin 150 MG Oral CapsuleSCD1f1b9230-b8ef-b0e4-e063-6394a90afc473
197518clindamycin 150 MG Oral CapsuleSCD2178249b-a9fe-5015-e063-6294a90a9ff43
197518clindamycin 150 MG Oral CapsuleSCD51dfa3fa-6f6a-4904-a8d3-b5938cf9c8523
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY1f1b9230-b8ef-b0e4-e063-6394a90afc473
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY2178249b-a9fe-5015-e063-6294a90a9ff43
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY51dfa3fa-6f6a-4904-a8d3-b5938cf9c8523
197518clindamycin HCl 150 MG Oral CapsulePSN2290109b-45c9-1aab-e063-6294a90a673b1
197518clindamycin HCl 150 MG Oral CapsulePSN47f76d99-2024-4531-a527-66c80deeeb371
197518clindamycin HCl 150 MG Oral CapsulePSNfa084aad-07fa-44d2-8d01-d32f40acd2f31
197518clindamycin HCl 150 MG Oral CapsulePSN26a4ef90-cd36-5052-e063-6294a90a69ba1
197518clindamycin HCl 150 MG Oral CapsulePSN2de041be-1d36-ee95-e063-6294a90a20911
197518clindamycin 150 MG Oral CapsuleSCDfa084aad-07fa-44d2-8d01-d32f40acd2f31
197518clindamycin 150 MG Oral CapsuleSCD47f76d99-2024-4531-a527-66c80deeeb371
197518clindamycin 150 MG Oral CapsuleSCD2de041be-1d36-ee95-e063-6294a90a20911
197518clindamycin 150 MG Oral CapsuleSCD26a4ef90-cd36-5052-e063-6294a90a69ba1
197518clindamycin 150 MG Oral CapsuleSCD2290109b-45c9-1aab-e063-6294a90a673b1
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY47f76d99-2024-4531-a527-66c80deeeb371
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY2de041be-1d36-ee95-e063-6294a90a20911
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY26a4ef90-cd36-5052-e063-6294a90a69ba1
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSYfa084aad-07fa-44d2-8d01-d32f40acd2f31
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY2290109b-45c9-1aab-e063-6294a90a673b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68462-143-0168462014301100 CAPSULE in 1 BOTTLE (68462-143-01) 100 capsule2023-03-10NoNoHistorical
68462-143-0568462014305500 CAPSULE in 1 BOTTLE (68462-143-05) 500 capsule2023-03-10NoNoHistorical