FDA.reportPublic FDA data

CLINDAMYCIN HYDROCHLORIDE

Product NDC
72789-167
11-digit product format
727890167
Labeler code
72789
Product ID
72789-167_4af7c823-02f5-eb36-e063-6394a90a7c17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CLINDAMYCIN HYDROCHLORIDE
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-167-09CLINDAMYCIN HYDROCHLORIDE9 in 1 BOTTLE, PLASTICCAPSULE916
72789-167-20CLINDAMYCIN HYDROCHLORIDE20 in 1 BOTTLE, PLASTICCAPSULE2016
72789-167-21CLINDAMYCIN HYDROCHLORIDE21 in 1 BOTTLE, PLASTICCAPSULE2116
72789-167-30CLINDAMYCIN HYDROCHLORIDE30 in 1 BOTTLE, PLASTICCAPSULE3016
72789-167-40CLINDAMYCIN HYDROCHLORIDE40 in 1 BOTTLE, PLASTICCAPSULE4016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-167CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 5 package rows20240905_8e3c9cf6-ab39-4fb5-94e3-232880c47700.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284215clindamycin HCl 300 MG Oral CapsulePSN8e3c9cf6-ab39-4fb5-94e3-232880c4770016
284215clindamycin 300 MG Oral CapsuleSCD8e3c9cf6-ab39-4fb5-94e3-232880c4770016
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY8e3c9cf6-ab39-4fb5-94e3-232880c4770016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-167-09727890167099 CAPSULE in 1 BOTTLE, PLASTIC (72789-167-09) 9 capsule2021-07-090000-00-00NoNoCurrent
72789-167-207278901672020 CAPSULE in 1 BOTTLE, PLASTIC (72789-167-20) 20 capsule2021-02-260000-00-00NoNoCurrent
72789-167-217278901672121 CAPSULE in 1 BOTTLE, PLASTIC (72789-167-21) 21 capsule2021-02-260000-00-00NoNoCurrent
72789-167-307278901673030 CAPSULE in 1 BOTTLE, PLASTIC (72789-167-30) 30 capsule2021-02-220000-00-00NoNoCurrent
72789-167-407278901674040 CAPSULE in 1 BOTTLE, PLASTIC (72789-167-40) 40 capsule2021-05-180000-00-00NoNoCurrent