FDA.reportPublic FDA data

Clindamycin Hydrochloride

Product NDC
50090-0443
11-digit product format
500900443
Labeler code
50090
Product ID
50090-0443_33825777-3310-4c32-9f4b-3e6d12d3315d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065442
Marketing category
ANDA
Marketing start
2009-08-26
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT20OQ1YN1W
Rxcui197518

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
50090-0443-0Clindamycin Hydrochloride30 in 1 BOTTLECAPSULE309
50090-0443-1Clindamycin Hydrochloride15 in 1 BOTTLECAPSULE159
50090-0443-3Clindamycin Hydrochloride4 in 1 BOTTLECAPSULE49
50090-0443-4Clindamycin Hydrochloride100 in 1 BOTTLECAPSULE1009
50090-0443-6Clindamycin Hydrochloride21 in 1 BOTTLECAPSULE219
50090-0443-7Clindamycin Hydrochloride42 in 1 BOTTLECAPSULE429

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0443-0EA - Each50090-04437237aa3e-9011-40c0-9960-1f4a3f4862fa12018-08-13
50090-0443-1EA - Each50090-04434932b941-7c95-418d-82eb-fc07ea5173ee12018-09-05
50090-0443-3EA - Each50090-04439f3bc697-8903-4b7a-99b7-c50a4478ffb012024-10-04
50090-0443-4EA - Each50090-04433bb09dfe-e6cc-4287-9377-7753080f2d1612018-09-05
50090-0443-6EA - Each50090-044367ed8cf4-3377-4a30-b582-be45f248b84512024-10-04
50090-0443-7EA - Each50090-0443bf72a3ce-9cb8-4418-ad61-eb8647ad6d2912018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0443CLINDAMYCIN HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 6 package rows20240905_8af1493c-1f22-4629-a432-f8b0578189e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSN8af1493c-1f22-4629-a432-f8b0578189e19
197518clindamycin 150 MG Oral CapsuleSCD8af1493c-1f22-4629-a432-f8b0578189e19
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY8af1493c-1f22-4629-a432-f8b0578189e19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-0443-05009004430030 CAPSULE in 1 BOTTLE (50090-0443-0) 30 capsule2016-06-29NoNoHistorical
50090-0443-15009004430115 CAPSULE in 1 BOTTLE (50090-0443-1) 15 capsule2016-06-29NoNoHistorical
50090-0443-3500900443034 CAPSULE in 1 BOTTLE (50090-0443-3) 4 capsule2016-06-29NoNoHistorical
50090-0443-450090044304100 CAPSULE in 1 BOTTLE (50090-0443-4) 100 capsule2016-06-29NoNoHistorical
50090-0443-65009004430621 CAPSULE in 1 BOTTLE (50090-0443-6) 21 capsule2016-06-29NoNoHistorical
50090-0443-75009004430742 CAPSULE in 1 BOTTLE (50090-0443-7) 42 capsule2016-06-29NoNoHistorical