FDA.reportPublic FDA data

Clindamycin Hydrochloride

Product NDC
50090-3907
11-digit product format
500903907
Labeler code
50090
Product ID
50090-3907_7cc94978-0e5a-4b5e-b09d-55cc9428e7ef
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3907-02023-08-27C16284748780-1f386c649-d1cf-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP Rx only
50090-3907-12023-08-27C16284748780-1f386c649-d1cf-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP Rx only
50090-3907-22023-08-27C16284748780-1f386c649-d1cf-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP Rx only
50090-3907-32023-08-27C16284748780-1f386c649-d1cf-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP Rx only
50090-3907-02023-01-30C16284748780-1f386c649-d1cf-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP Rx only
50090-3907-12023-01-30C16284748780-1f386c649-d1cf-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP Rx only
50090-3907-22023-01-30C16284748780-1f386c649-d1cf-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP Rx only
50090-3907-32023-01-30C16284748780-1f386c649-d1cf-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3907-0Clindamycin Hydrochloride30 in 1 BOTTLECAPSULE308
50090-3907-1Clindamycin Hydrochloride45 in 1 BOTTLECAPSULE458
50090-3907-2Clindamycin Hydrochloride16 in 1 BOTTLECAPSULE168
50090-3907-3Clindamycin Hydrochloride40 in 1 BOTTLECAPSULE408
50090-3907-4Clindamycin Hydrochloride20 in 1 BOTTLECAPSULE208
50090-3907-5Clindamycin Hydrochloride3 in 1 BOTTLECAPSULE38

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3907-0EA - Each50090-39071f7a0d8c-b60a-4404-9d46-f81026c4f00b12023-10-16
50090-3907-1EA - Each50090-39076d1b987d-51a6-46a4-bee0-71503c4b22bf12023-10-16
50090-3907-2EA - Each50090-39075f9d5630-d105-4a1a-af12-e068b0fdcd2112023-10-16
50090-3907-3EA - Each50090-3907a667e49a-0b8d-4620-8358-a283c5703a9b12023-10-16
50090-3907-4EA - Each50090-3907a3e4008f-32a8-4cf1-8445-926a62eeb5db12023-10-16
50090-3907-5EA - Each50090-39075267b6f9-0c0d-4a11-b5f8-c1d3406dbc3d12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3907CLINDAMYCIN HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 6 package rows20240521_2393251d-33b9-4274-9d04-27ec9968eaa1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284215clindamycin HCl 300 MG Oral CapsulePSN2393251d-33b9-4274-9d04-27ec9968eaa18
284215clindamycin 300 MG Oral CapsuleSCD2393251d-33b9-4274-9d04-27ec9968eaa18
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY2393251d-33b9-4274-9d04-27ec9968eaa18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3907-05009039070030 CAPSULE in 1 BOTTLE (50090-3907-0) 30 capsule2018-12-050000-00-00NoNoCurrent
50090-3907-15009039070145 CAPSULE in 1 BOTTLE (50090-3907-1) 45 capsule2018-12-050000-00-00NoNoCurrent
50090-3907-25009039070216 CAPSULE in 1 BOTTLE (50090-3907-2) 16 capsule2018-12-050000-00-00NoNoCurrent
50090-3907-35009039070340 CAPSULE in 1 BOTTLE (50090-3907-3) 40 capsule2018-12-050000-00-00NoNoCurrent
50090-3907-45009039070420 CAPSULE in 1 BOTTLE (50090-3907-4) 20 capsule2018-12-05NoNoCurrent
50090-3907-5500903907053 CAPSULE in 1 BOTTLE (50090-3907-5) 3 capsule2024-05-14NoNoCurrent