FDA.reportPublic FDA data

Clindamycin Hydrochloride

Product NDC
50090-7354
11-digit product format
500907354
Labeler code
50090
Product ID
50090-7354_d005db80-b81e-4587-8a6d-8004770e1720
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA216957
Marketing category
ANDA
Marketing start
2023-03-10
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clindamycin Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT20OQ1YN1W
Rxcui284215

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
50090-7354-0Clindamycin Hydrochloride30 in 1 BOTTLECAPSULE301
50090-7354-1Clindamycin Hydrochloride45 in 1 BOTTLECAPSULE451
50090-7354-2Clindamycin Hydrochloride16 in 1 BOTTLECAPSULE161
50090-7354-3Clindamycin Hydrochloride40 in 1 BOTTLECAPSULE401
50090-7354-4Clindamycin Hydrochloride20 in 1 BOTTLECAPSULE201
50090-7354-5Clindamycin Hydrochloride3 in 1 BOTTLECAPSULE31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7354-0EA - Each50090-7354207ce56c-a2e6-4561-89c3-5451cf676bf712024-11-05
50090-7354-1EA - Each50090-73541405275f-b538-4740-962c-2d86b0cfad1e12024-11-05
50090-7354-2EA - Each50090-7354afcaec40-be0a-4296-a58a-4dfa1c583bd412024-11-05
50090-7354-3EA - Each50090-735487940718-27f4-479e-ae6b-e47fe22a86cb12024-11-05
50090-7354-4EA - Each50090-7354ba5c3b30-3eba-408d-a5e9-8af2e358eadf12024-11-05
50090-7354-5EA - Each50090-7354072b8899-0750-483c-aa77-83b4cfb8ff2212024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7354CLINDAMYCIN HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]1Current NDC, 6 package rows20241023_7b110bab-815e-4654-860b-b9142fd93d45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284215clindamycin HCl 300 MG Oral CapsulePSN7b110bab-815e-4654-860b-b9142fd93d451
284215clindamycin 300 MG Oral CapsuleSCD7b110bab-815e-4654-860b-b9142fd93d451
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY7b110bab-815e-4654-860b-b9142fd93d451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7354-05009073540030 CAPSULE in 1 BOTTLE (50090-7354-0) 30 capsule2024-10-16NoNoCurrent
50090-7354-15009073540145 CAPSULE in 1 BOTTLE (50090-7354-1) 45 capsule2024-10-16NoNoCurrent
50090-7354-25009073540216 CAPSULE in 1 BOTTLE (50090-7354-2) 16 capsule2024-10-16NoNoCurrent
50090-7354-35009073540340 CAPSULE in 1 BOTTLE (50090-7354-3) 40 capsule2024-10-16NoNoCurrent
50090-7354-45009073540420 CAPSULE in 1 BOTTLE (50090-7354-4) 20 capsule2024-10-16NoNoCurrent
50090-7354-5500907354053 CAPSULE in 1 BOTTLE (50090-7354-5) 3 capsule2024-10-16NoNoCurrent