Clindamycin Phosphate

Product NDC
10135-691
11-digit product format
101350691
Labeler code
10135
Product ID
10135-691_ec98a8b7-7c90-6912-e053-2a95a90a2791
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Phosphate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA209846
Marketing category
ANDA
Marketing start
2020-03-01
Marketing end
0000-00-00
Substance
CLINDAMYCIN PHOSPHATE
Active strength
12 mg/mL
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
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
10135-691-612024-01-30C16284748780-11030e365-352b-111a-e063-dadaa90a10e2Clindamycin Phosphate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-691-61Clindamycin Phosphate1 in 1 CARTONSOLUTION14
10135-691-61Clindamycin Phosphate60 mL in 1 BOTTLE, WITH APPLICATORSOLUTION604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-691-61ML - Milliliter10135-691aa900cb1-9b0d-45c2-8cc5-cbe1f9367eec12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-691CLINDAMYCIN PHOSPHATE SOLUTION [MARLEX PHARMACEUTICALS INC]4Legacy NDC, 2 package rows20221104_ab4e9054-348c-4e7b-ae04-1163ac9a15f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309333clindamycin phosphate 1 % Topical SolutionPSNab4e9054-348c-4e7b-ae04-1163ac9a15f94
309333clindamycin 10 MG/ML Topical SolutionSCDab4e9054-348c-4e7b-ae04-1163ac9a15f94
309333clindamycin (as clindamycin phosphate) 1 % Topical SolutionSYab4e9054-348c-4e7b-ae04-1163ac9a15f94
309333clindamycin 1 % Topical SolutionSYab4e9054-348c-4e7b-ae04-1163ac9a15f94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10135-691-61101350691611 BOTTLE, WITH APPLICATOR in 1 CARTON (10135-691-61) > 60 mL in 1 BOTTLE, WITH APPLICATOR2020-03-010000-00-00NoNoCurrent