FDA.reportPublic FDA data

CLINDAMYCIN HYDROCHLORIDE

Product NDC
72789-180
11-digit product format
727890180
Labeler code
72789
Product ID
72789-180_4b070970-5307-a98b-e063-6394a90aca94
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
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
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 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
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
72789-180-04CLINDAMYCIN HYDROCHLORIDE4 in 1 BOTTLE, PLASTICCAPSULE421
72789-180-06CLINDAMYCIN HYDROCHLORIDE6 in 1 BOTTLE, PLASTICCAPSULE621
72789-180-08CLINDAMYCIN HYDROCHLORIDE8 in 1 BOTTLE, PLASTICCAPSULE821
72789-180-15CLINDAMYCIN HYDROCHLORIDE15 in 1 BOTTLE, PLASTICCAPSULE1521
72789-180-20CLINDAMYCIN HYDROCHLORIDE20 in 1 BOTTLE, PLASTICCAPSULE2021
72789-180-21CLINDAMYCIN HYDROCHLORIDE21 in 1 BOTTLE, PLASTICCAPSULE2121
72789-180-28CLINDAMYCIN HYDROCHLORIDE28 in 1 BOTTLE, PLASTICCAPSULE2821
72789-180-30CLINDAMYCIN HYDROCHLORIDE30 in 1 BOTTLE, PLASTICCAPSULE3021
72789-180-40CLINDAMYCIN HYDROCHLORIDE40 in 1 BOTTLE, PLASTICCAPSULE4021
72789-180-42CLINDAMYCIN HYDROCHLORIDE42 in 1 BOTTLE, PLASTICCAPSULE4221
72789-180-56CLINDAMYCIN HYDROCHLORIDE56 in 1 BOTTLE, PLASTICCAPSULE5621

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-180-04EA - Each72789-180f39fc80c-aa81-4902-8454-6702ab0d8cdd12021-08-05
72789-180-06EA - Each72789-18037e02a9a-c69c-4615-8402-9dad9607269412021-08-05
72789-180-08EA - Each72789-180edd72086-bced-4dca-89eb-f43f3e9242a512021-11-09
72789-180-15EA - Each72789-180057ed8fe-aef0-4abc-8925-8f65cf59494912021-08-05
72789-180-20EA - Each72789-180f1d443bc-4955-47f4-9d21-270b8961c2b312021-11-09
72789-180-21EA - Each72789-1805b530438-2acd-4d9f-9c9a-6ed92d1849bb12021-11-09
72789-180-28EA - Each72789-1800ad5df30-038f-4b63-918e-a189c5e3fabf12021-05-05
72789-180-30EA - Each72789-18047178192-d563-4030-8a3a-0b597cdc624112021-07-15
72789-180-40EA - Each72789-1806325361f-40f1-4437-8dce-8f7a7b42fb4a12022-08-04
72789-180-42EA - Each72789-180aae719db-b9e8-4faa-b4bb-13e3b44ec75c12021-11-09
72789-180-56EA - Each72789-180d77aa8c8-e20c-413e-8a29-bd4820fd669912022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-180CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]19Current NDC, Legacy NDC, 11 package rows20240905_de7001d1-8b83-4f8b-8e50-c07691021456.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSNde7001d1-8b83-4f8b-8e50-c0769102145621
197518clindamycin 150 MG Oral CapsuleSCDde7001d1-8b83-4f8b-8e50-c0769102145621
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSYde7001d1-8b83-4f8b-8e50-c0769102145621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-180-04727890180044 CAPSULE in 1 BOTTLE, PLASTIC (72789-180-04) 4 capsule2021-06-290000-00-00NoNoCurrent
72789-180-06727890180066 CAPSULE in 1 BOTTLE, PLASTIC (72789-180-06) 6 capsule2021-07-080000-00-00NoNoCurrent
72789-180-08727890180088 CAPSULE in 1 BOTTLE, PLASTIC (72789-180-08) 8 capsule2021-09-270000-00-00NoNoCurrent
72789-180-157278901801515 CAPSULE in 1 BOTTLE, PLASTIC (72789-180-15) 15 capsule2021-07-080000-00-00NoNoCurrent
72789-180-207278901802020 CAPSULE in 1 BOTTLE, PLASTIC (72789-180-20) 20 capsule2021-09-270000-00-00NoNoCurrent
72789-180-217278901802121 CAPSULE in 1 BOTTLE, PLASTIC (72789-180-21) 21 capsule2021-08-110000-00-00NoNoCurrent
72789-180-287278901802828 CAPSULE in 1 BOTTLE, PLASTIC (72789-180-28) 28 capsule2021-03-300000-00-00NoNoCurrent
72789-180-307278901803030 CAPSULE in 1 BOTTLE, PLASTIC (72789-180-30) 30 capsule2021-06-230000-00-00NoNoCurrent
72789-180-407278901804040 CAPSULE in 1 BOTTLE, PLASTIC (72789-180-40) 40 capsule2022-05-310000-00-00NoNoCurrent
72789-180-427278901804242 CAPSULE in 1 BOTTLE, PLASTIC (72789-180-42) 42 capsule2021-08-120000-00-00NoNoCurrent
72789-180-567278901805656 CAPSULE in 1 BOTTLE, PLASTIC (72789-180-56) 56 capsule2022-04-260000-00-00NoNoCurrent