FDA.reportPublic FDA data

CLINDAMYCIN HYDROCHLORIDE

Product NDC
50090-4575
11-digit product format
500904575
Labeler code
50090
Product ID
50090-4575_aa5114bb-9acc-4fe5-9bc5-b9205435122f
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
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
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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
50090-4575-02023-02-07C16284748780-1f386c64a-3f54-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
50090-4575-12023-02-07C16284748780-1f386c64a-3f54-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
50090-4575-22023-02-07C16284748780-1f386c64a-3f54-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
50090-4575-32023-02-07C16284748780-1f386c64a-3f54-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
50090-4575-42023-02-07C16284748780-1f386c64a-3f54-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
50090-4575-02023-01-30C16284748780-1f386c64a-3f54-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
50090-4575-12023-01-30C16284748780-1f386c64a-3f54-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
50090-4575-22023-01-30C16284748780-1f386c64a-3f54-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
50090-4575-32023-01-30C16284748780-1f386c64a-3f54-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP
50090-4575-42023-01-30C16284748780-1f386c64a-3f54-0266-e053-dadaa90a7c1aClindamycin Hydrochloride Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4575-0CLINDAMYCIN HYDROCHLORIDE30 in 1 BOTTLECAPSULE308
50090-4575-1CLINDAMYCIN HYDROCHLORIDE45 in 1 BOTTLECAPSULE458
50090-4575-2CLINDAMYCIN HYDROCHLORIDE16 in 1 BOTTLECAPSULE168
50090-4575-3CLINDAMYCIN HYDROCHLORIDE40 in 1 BOTTLECAPSULE408
50090-4575-4CLINDAMYCIN HYDROCHLORIDE20 in 1 BOTTLECAPSULE208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4575-0EA - Each50090-4575219e22d5-e19d-4d3d-9704-573aef6147be12021-04-08
50090-4575-1EA - Each50090-4575aeeed2f6-461e-41f4-99ae-997f39b91a2b12022-12-07
50090-4575-2EA - Each50090-457544741a32-3290-4e92-a592-7572b17f7a0812022-12-07
50090-4575-3EA - Each50090-4575260adcd4-e4ca-446d-82c7-eaf868cd620d12022-12-07
50090-4575-4EA - Each50090-457561a701e9-20e7-4796-95dc-34cc82ba1f2212022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4575CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 5 package rows20230208_07f5d841-9c58-4dd1-b0bc-e12553931c8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284215clindamycin HCl 300 MG Oral CapsulePSN07f5d841-9c58-4dd1-b0bc-e12553931c8e8
284215clindamycin 300 MG Oral CapsuleSCD07f5d841-9c58-4dd1-b0bc-e12553931c8e8
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY07f5d841-9c58-4dd1-b0bc-e12553931c8e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4575-05009045750030 CAPSULE in 1 BOTTLE (50090-4575-0) 30 capsule2019-10-040000-00-00NoNoCurrent
50090-4575-15009045750145 CAPSULE in 1 BOTTLE (50090-4575-1) 45 capsule2019-10-040000-00-00NoNoCurrent
50090-4575-25009045750216 CAPSULE in 1 BOTTLE (50090-4575-2) 16 capsule2019-10-040000-00-00NoNoCurrent
50090-4575-35009045750340 CAPSULE in 1 BOTTLE (50090-4575-3) 40 capsule2019-10-040000-00-00NoNoCurrent
50090-4575-45009045750420 CAPSULE in 1 BOTTLE (50090-4575-4) 20 capsule2019-10-040000-00-00NoNoCurrent