FDA.reportPublic FDA data

CLINDAMYCIN HYDROCHLORIDE

Product NDC
71335-1412
11-digit product format
713351412
Labeler code
71335
Product ID
71335-1412_27503215-1a2f-4f43-9df3-16b2f027d53a
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
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
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
71335-1412-0CLINDAMYCIN HYDROCHLORIDE16 in 1 BOTTLECAPSULE1611
71335-1412-1CLINDAMYCIN HYDROCHLORIDE30 in 1 BOTTLECAPSULE3011
71335-1412-2CLINDAMYCIN HYDROCHLORIDE20 in 1 BOTTLECAPSULE2011
71335-1412-3CLINDAMYCIN HYDROCHLORIDE40 in 1 BOTTLECAPSULE4011
71335-1412-4CLINDAMYCIN HYDROCHLORIDE21 in 1 BOTTLECAPSULE2111
71335-1412-5CLINDAMYCIN HYDROCHLORIDE28 in 1 BOTTLECAPSULE2811
71335-1412-6CLINDAMYCIN HYDROCHLORIDE12 in 1 BOTTLECAPSULE1211
71335-1412-7CLINDAMYCIN HYDROCHLORIDE120 in 1 BOTTLECAPSULE12011
71335-1412-8CLINDAMYCIN HYDROCHLORIDE14 in 1 BOTTLECAPSULE1411
71335-1412-9CLINDAMYCIN HYDROCHLORIDE45 in 1 BOTTLECAPSULE4511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1412-1EA - Each71335-1412e16b1df6-16a8-424a-a048-dd03bfcb7f6e12022-04-06
71335-1412-5EA - Each71335-1412b4f371df-0afd-480d-9aeb-6fcc8e2a3e6412023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1412CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]11Current NDC, Legacy NDC, 10 package rows20240809_bea7de4c-c077-4535-96a0-f6b319120b0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284215clindamycin HCl 300 MG Oral CapsulePSNbea7de4c-c077-4535-96a0-f6b319120b0b11
284215clindamycin 300 MG Oral CapsuleSCDbea7de4c-c077-4535-96a0-f6b319120b0b11
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSYbea7de4c-c077-4535-96a0-f6b319120b0b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1412-07133514120016 CAPSULE in 1 BOTTLE (71335-1412-0) 16 capsule2021-08-300000-00-00NoNoCurrent
71335-1412-17133514120130 CAPSULE in 1 BOTTLE (71335-1412-1) 30 capsule2019-11-180000-00-00NoNoCurrent
71335-1412-27133514120220 CAPSULE in 1 BOTTLE (71335-1412-2) 20 capsule2020-01-140000-00-00NoNoCurrent
71335-1412-37133514120340 CAPSULE in 1 BOTTLE (71335-1412-3) 40 capsule2019-12-240000-00-00NoNoCurrent
71335-1412-47133514120421 CAPSULE in 1 BOTTLE (71335-1412-4) 21 capsule2019-12-160000-00-00NoNoCurrent
71335-1412-57133514120528 CAPSULE in 1 BOTTLE (71335-1412-5) 28 capsule2020-01-230000-00-00NoNoCurrent
71335-1412-67133514120612 CAPSULE in 1 BOTTLE (71335-1412-6) 12 capsule2022-06-300000-00-00NoNoCurrent
71335-1412-771335141207120 CAPSULE in 1 BOTTLE (71335-1412-7) 120 capsule2019-12-120000-00-00NoNoCurrent
71335-1412-87133514120814 CAPSULE in 1 BOTTLE (71335-1412-8) 14 capsule2019-12-190000-00-00NoNoCurrent
71335-1412-97133514120945 CAPSULE in 1 BOTTLE (71335-1412-9) 45 capsule2020-03-180000-00-00NoNoCurrent