FDA.reportPublic FDA data

CLINDAMYCIN HYDROCHLORIDE

Product NDC
71335-1489
11-digit product format
713351489
Labeler code
71335
Product ID
71335-1489_ee11ff48-5112-45a9-b629-4f9706f574b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT20OQ1YN1W

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
71335-1489-0CLINDAMYCIN HYDROCHLORIDE40 in 1 BOTTLECAPSULE40104
71335-1489-1CLINDAMYCIN HYDROCHLORIDE12 in 1 BOTTLECAPSULE12104
71335-1489-2CLINDAMYCIN HYDROCHLORIDE28 in 1 BOTTLECAPSULE28104
71335-1489-3CLINDAMYCIN HYDROCHLORIDE42 in 1 BOTTLECAPSULE42104
71335-1489-4CLINDAMYCIN HYDROCHLORIDE60 in 1 BOTTLECAPSULE60104
71335-1489-5CLINDAMYCIN HYDROCHLORIDE30 in 1 BOTTLECAPSULE30104
71335-1489-6CLINDAMYCIN HYDROCHLORIDE21 in 1 BOTTLECAPSULE21104
71335-1489-7CLINDAMYCIN HYDROCHLORIDE4 in 1 BOTTLECAPSULE4104
71335-1489-8CLINDAMYCIN HYDROCHLORIDE56 in 1 BOTTLECAPSULE56104
71335-1489-9CLINDAMYCIN HYDROCHLORIDE20 in 1 BOTTLECAPSULE20104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1489CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 10 package rows20240809_5f6a85c5-dca3-49b1-a029-3818a41d49bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSN5f6a85c5-dca3-49b1-a029-3818a41d49bf104
197518clindamycin 150 MG Oral CapsuleSCD5f6a85c5-dca3-49b1-a029-3818a41d49bf104
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY5f6a85c5-dca3-49b1-a029-3818a41d49bf104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1489-07133514890040 CAPSULE in 1 BOTTLE (71335-1489-0) 40 capsule2020-02-170000-00-00NoNoCurrent
71335-1489-17133514890112 CAPSULE in 1 BOTTLE (71335-1489-1) 12 capsule2021-02-240000-00-00NoNoCurrent
71335-1489-27133514890228 CAPSULE in 1 BOTTLE (71335-1489-2) 28 capsule2020-08-070000-00-00NoNoCurrent
71335-1489-37133514890342 CAPSULE in 1 BOTTLE (71335-1489-3) 42 capsule2020-02-060000-00-00NoNoCurrent
71335-1489-47133514890460 CAPSULE in 1 BOTTLE (71335-1489-4) 60 capsule2020-03-190000-00-00NoNoCurrent
71335-1489-57133514890530 CAPSULE in 1 BOTTLE (71335-1489-5) 30 capsule2020-01-310000-00-00NoNoCurrent
71335-1489-67133514890621 CAPSULE in 1 BOTTLE (71335-1489-6) 21 capsule2020-01-290000-00-00NoNoCurrent
71335-1489-7713351489074 CAPSULE in 1 BOTTLE (71335-1489-7) 4 capsule2022-06-300000-00-00NoNoCurrent
71335-1489-87133514890856 CAPSULE in 1 BOTTLE (71335-1489-8) 56 capsule2022-06-300000-00-00NoNoCurrent
71335-1489-97133514890920 CAPSULE in 1 BOTTLE (71335-1489-9) 20 capsule2020-09-240000-00-00NoNoCurrent