FDA.reportPublic FDA data

Clindamycin Hydrochloride

Product NDC
71335-2623
11-digit product format
713352623
Labeler code
71335
Product ID
71335-2623_39886120-eb1b-40a8-a299-cad98aba87de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2026-12-31
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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2623-0Clindamycin Hydrochloride40 in 1 BOTTLECAPSULE401
71335-2623-1Clindamycin Hydrochloride12 in 1 BOTTLECAPSULE121
71335-2623-2Clindamycin Hydrochloride28 in 1 BOTTLECAPSULE281
71335-2623-3Clindamycin Hydrochloride42 in 1 BOTTLECAPSULE421
71335-2623-4Clindamycin Hydrochloride60 in 1 BOTTLECAPSULE601
71335-2623-5Clindamycin Hydrochloride30 in 1 BOTTLECAPSULE301
71335-2623-6Clindamycin Hydrochloride21 in 1 BOTTLECAPSULE211
71335-2623-7Clindamycin Hydrochloride4 in 1 BOTTLECAPSULE41
71335-2623-8Clindamycin Hydrochloride56 in 1 BOTTLECAPSULE561
71335-2623-9Clindamycin Hydrochloride20 in 1 BOTTLECAPSULE201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSN47f76d99-2024-4531-a527-66c80deeeb371
197518clindamycin 150 MG Oral CapsuleSCD47f76d99-2024-4531-a527-66c80deeeb371
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY47f76d99-2024-4531-a527-66c80deeeb371

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2623-07133526230040 CAPSULE in 1 BOTTLE (71335-2623-0) 40 capsule2025-06-03NoNoCurrent
71335-2623-17133526230112 CAPSULE in 1 BOTTLE (71335-2623-1) 12 capsule2025-06-03NoNoCurrent
71335-2623-27133526230228 CAPSULE in 1 BOTTLE (71335-2623-2) 28 capsule2025-06-03NoNoCurrent
71335-2623-37133526230342 CAPSULE in 1 BOTTLE (71335-2623-3) 42 capsule2025-06-03NoNoCurrent
71335-2623-47133526230460 CAPSULE in 1 BOTTLE (71335-2623-4) 60 capsule2025-06-03NoNoCurrent
71335-2623-57133526230530 CAPSULE in 1 BOTTLE (71335-2623-5) 30 capsule2025-06-03NoNoCurrent
71335-2623-67133526230621 CAPSULE in 1 BOTTLE (71335-2623-6) 21 capsule2025-06-03NoNoCurrent
71335-2623-7713352623074 CAPSULE in 1 BOTTLE (71335-2623-7) 4 capsule2025-06-03NoNoCurrent
71335-2623-87133526230856 CAPSULE in 1 BOTTLE (71335-2623-8) 56 capsule2025-06-03NoNoCurrent
71335-2623-97133526230920 CAPSULE in 1 BOTTLE (71335-2623-9) 20 capsule2025-06-03NoNoCurrent