FDA.reportPublic FDA data

CLINDAMYCIN HYDROCHLORIDE

Product NDC
50090-4661
11-digit product format
500904661
Labeler code
50090
Product ID
50090-4661_dc91f2f3-c5e8-4c78-aec4-ad45e327bfa4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207402
Marketing category
ANDA
Marketing start
2019-01-07
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4661-02023-02-07C16284748780-1f386c649-b1c5-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
50090-4661-12023-02-07C16284748780-1f386c649-b1c5-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
50090-4661-32023-02-07C16284748780-1f386c649-b1c5-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
50090-4661-42023-02-07C16284748780-1f386c649-b1c5-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
50090-4661-62023-02-07C16284748780-1f386c649-b1c5-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
50090-4661-72023-02-07C16284748780-1f386c649-b1c5-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
50090-4661-02023-01-30C16284748780-1f386c649-b1c5-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
50090-4661-12023-01-30C16284748780-1f386c649-b1c5-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
50090-4661-32023-01-30C16284748780-1f386c649-b1c5-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
50090-4661-42023-01-30C16284748780-1f386c649-b1c5-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
50090-4661-62023-01-30C16284748780-1f386c649-b1c5-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
50090-4661-72023-01-30C16284748780-1f386c649-b1c5-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4661-0CLINDAMYCIN HYDROCHLORIDE30 in 1 BOTTLECAPSULE306
50090-4661-1CLINDAMYCIN HYDROCHLORIDE15 in 1 BOTTLECAPSULE156
50090-4661-3CLINDAMYCIN HYDROCHLORIDE4 in 1 BOTTLECAPSULE46
50090-4661-4CLINDAMYCIN HYDROCHLORIDE100 in 1 BOTTLECAPSULE1006
50090-4661-6CLINDAMYCIN HYDROCHLORIDE21 in 1 BOTTLECAPSULE216
50090-4661-7CLINDAMYCIN HYDROCHLORIDE42 in 1 BOTTLECAPSULE426

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4661-0EA - Each50090-4661817f6585-da12-4617-a1d4-77979d65c5bf12022-12-07
50090-4661-1EA - Each50090-4661dad70a71-3b8a-4cce-ab9d-e2ddb37d994012022-12-07
50090-4661-3EA - Each50090-46614c1d04f1-9795-499f-be29-a6edc056330112022-12-07
50090-4661-4EA - Each50090-46616f9b2b90-aa73-485e-af1a-a0a30179316612022-12-07
50090-4661-6EA - Each50090-4661e68bacd7-ead9-4633-bc67-07844823846012022-12-07
50090-4661-7EA - Each50090-46612e744fbc-4046-461b-b5dc-4553e94fff9b12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4661CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 6 package rows20230208_18ef4551-4066-4765-90cb-285d7711cf61.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSN18ef4551-4066-4765-90cb-285d7711cf616
197518clindamycin 150 MG Oral CapsuleSCD18ef4551-4066-4765-90cb-285d7711cf616
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY18ef4551-4066-4765-90cb-285d7711cf616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4661-05009046610030 CAPSULE in 1 BOTTLE (50090-4661-0) 30 capsule2019-10-290000-00-00NoNoCurrent
50090-4661-15009046610115 CAPSULE in 1 BOTTLE (50090-4661-1) 15 capsule2019-10-290000-00-00NoNoCurrent
50090-4661-3500904661034 CAPSULE in 1 BOTTLE (50090-4661-3) 4 capsule2019-10-290000-00-00NoNoCurrent
50090-4661-450090466104100 CAPSULE in 1 BOTTLE (50090-4661-4) 100 capsule2019-10-290000-00-00NoNoCurrent
50090-4661-65009046610621 CAPSULE in 1 BOTTLE (50090-4661-6) 21 capsule2019-10-290000-00-00NoNoCurrent
50090-4661-75009046610742 CAPSULE in 1 BOTTLE (50090-4661-7) 42 capsule2019-10-290000-00-00NoNoCurrent