FDA.reportPublic FDA data

CLINDAMYCIN HYDROCHLORIDE

Product NDC
70518-2153
11-digit product format
705182153
Labeler code
70518
Product ID
70518-2153_50b07de4-418a-db35-e063-6294a90a57c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207402
Marketing category
ANDA
Marketing start
2019-06-26
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2153-02021-02-19C16284748780-1ba0f9c33-352e-a910-e053-dadaa90a0b85Clindamycin Hydrochloride Capsules, USP
70518-2153-02021-02-19C16284748780-1ba0f9c33-352e-a910-e053-dadaa90a0b85Clindamycin Hydrochloride Capsules, USP
70518-2153-02021-02-19C16284748780-1ba0f9c33-352e-a910-e053-dadaa90a0b85Clindamycin Hydrochloride Capsules, USP
70518-2153-12021-02-19C16284748780-1ba0f9c33-352e-a910-e053-dadaa90a0b85Clindamycin Hydrochloride Capsules, USP
70518-2153-12021-02-19C16284748780-1ba0f9c33-352e-a910-e053-dadaa90a0b85Clindamycin Hydrochloride Capsules, USP
70518-2153-12021-02-19C16284748780-1ba0f9c33-352e-a910-e053-dadaa90a0b85Clindamycin Hydrochloride Capsules, USP
70518-2153-22021-02-19C16284748780-1ba0f9c33-352e-a910-e053-dadaa90a0b85Clindamycin Hydrochloride Capsules, USP
70518-2153-22021-02-19C16284748780-1ba0f9c33-352e-a910-e053-dadaa90a0b85Clindamycin Hydrochloride Capsules, USP
70518-2153-22021-02-19C16284748780-1ba0f9c33-352e-a910-e053-dadaa90a0b85Clindamycin Hydrochloride Capsules, USP
70518-2153-32021-02-19C16284748780-1ba0f9c33-352e-a910-e053-dadaa90a0b85Clindamycin Hydrochloride Capsules, USP
70518-2153-32021-02-19C16284748780-1ba0f9c33-352e-a910-e053-dadaa90a0b85Clindamycin Hydrochloride Capsules, USP
70518-2153-32021-02-19C16284748780-1ba0f9c33-352e-a910-e053-dadaa90a0b85Clindamycin Hydrochloride Capsules, USP
70518-2153-02021-01-29C16284748780-1ba0f9c33-352e-a910-e053-dadaa90a0b85Clindamycin Hydrochloride Capsules, USP
70518-2153-02021-01-29C16284748780-1ba0f9c33-352e-a910-e053-dadaa90a0b85Clindamycin Hydrochloride Capsules, USP
70518-2153-02021-01-29C16284748780-1ba0f9c33-352e-a910-e053-dadaa90a0b85Clindamycin Hydrochloride Capsules, USP
70518-2153-12021-01-29C16284748780-1ba0f9c33-352e-a910-e053-dadaa90a0b85Clindamycin Hydrochloride Capsules, USP
70518-2153-12021-01-29C16284748780-1ba0f9c33-352e-a910-e053-dadaa90a0b85Clindamycin Hydrochloride Capsules, USP
70518-2153-12021-01-29C16284748780-1ba0f9c33-352e-a910-e053-dadaa90a0b85Clindamycin Hydrochloride Capsules, USP
70518-2153-22021-01-29C16284748780-1ba0f9c33-352e-a910-e053-dadaa90a0b85Clindamycin Hydrochloride Capsules, USP
70518-2153-22021-01-29C16284748780-1ba0f9c33-352e-a910-e053-dadaa90a0b85Clindamycin Hydrochloride Capsules, USP
70518-2153-22021-01-29C16284748780-1ba0f9c33-352e-a910-e053-dadaa90a0b85Clindamycin Hydrochloride Capsules, USP
70518-2153-32021-01-29C16284748780-1ba0f9c33-352e-a910-e053-dadaa90a0b85Clindamycin Hydrochloride Capsules, USP
70518-2153-32021-01-29C16284748780-1ba0f9c33-352e-a910-e053-dadaa90a0b85Clindamycin Hydrochloride Capsules, USP
70518-2153-32021-01-29C16284748780-1ba0f9c33-352e-a910-e053-dadaa90a0b85Clindamycin Hydrochloride Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2153-0CLINDAMYCIN HYDROCHLORIDE30 in 1 BLISTER PACKCAPSULE3021
70518-2153-1CLINDAMYCIN HYDROCHLORIDE28 in 1 BLISTER PACKCAPSULE2821
70518-2153-2CLINDAMYCIN HYDROCHLORIDE20 in 1 BLISTER PACKCAPSULE2021
70518-2153-3CLINDAMYCIN HYDROCHLORIDE21 in 1 BLISTER PACKCAPSULE2121
70518-2153-4CLINDAMYCIN HYDROCHLORIDE16 in 1 BOTTLE, PLASTICCAPSULE1621
70518-2153-5CLINDAMYCIN HYDROCHLORIDE30 in 1 BOTTLE, PLASTICCAPSULE3021
70518-2153-6CLINDAMYCIN HYDROCHLORIDE21 in 1 BOTTLE, PLASTICCAPSULE2121
70518-2153-7CLINDAMYCIN HYDROCHLORIDE14 in 1 BOTTLE, PLASTICCAPSULE1421

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2153CLINDAMYCIN HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]16Current NDC, Legacy NDC, 8 package rows20250308_f4c4fce0-0472-45a3-b4c6-192d97ca1818.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284215clindamycin HCl 300 MG Oral CapsulePSNf4c4fce0-0472-45a3-b4c6-192d97ca181821
284215clindamycin 300 MG Oral CapsuleSCDf4c4fce0-0472-45a3-b4c6-192d97ca181821
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSYf4c4fce0-0472-45a3-b4c6-192d97ca181821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2153-07051821530030 CAPSULE in 1 BLISTER PACK (70518-2153-0) 30 capsule2019-06-260000-00-00NoNoCurrent
70518-2153-17051821530128 CAPSULE in 1 BLISTER PACK (70518-2153-1) 28 capsule2019-08-020000-00-00NoNoCurrent
70518-2153-27051821530220 CAPSULE in 1 BLISTER PACK (70518-2153-2) 20 capsule2019-08-120000-00-00NoNoCurrent
70518-2153-37051821530321 CAPSULE in 1 BLISTER PACK (70518-2153-3) 21 capsule2019-12-100000-00-00NoNoCurrent
70518-2153-47051821530416 CAPSULE in 1 BOTTLE, PLASTIC (70518-2153-4) 16 capsule2020-10-220000-00-00NoNoCurrent
70518-2153-57051821530530 CAPSULE in 1 BOTTLE, PLASTIC (70518-2153-5) 30 capsule2022-05-260000-00-00NoNoCurrent
70518-2153-67051821530621 CAPSULE in 1 BOTTLE, PLASTIC (70518-2153-6) 21 capsule2022-05-310000-00-00NoNoCurrent
70518-2153-77051821530714 CAPSULE in 1 BOTTLE, PLASTIC (70518-2153-7) 14 capsule2025-01-29NoNoCurrent