CLINDAMYCIN HYDROCHLORIDE

Product NDC
70518-2153
Requested package NDC
70518-2153-2
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-215370518-2153-2DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207402-001CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-05
A207402-002CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-05
A207402-003CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A207402-001AB
A207402-002AB
A207402-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-058072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207402-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207402-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207402-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207402-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207402-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207402-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207402-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207402-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207402-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207402-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207402-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207402-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207402-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207402-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207402-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207402-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207402-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207402-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207402-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207402-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207402-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207402-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207402-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207402-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207402-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207402-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207402-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207402-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207402-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207402-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207402-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207402-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207402-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207402-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207402-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207402-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207402-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207402-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207402-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207402-001AB18072bd15b7f6…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
T20OQ1YN1WInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
284215Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f4c4fce0-0472-45a3-b4c6-192d97ca1818Available on FDA.report

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, Related label table
NDCEffectiveRelated label
70518-2153-02021-02-19Clindamycin Hydrochloride Capsules, USP
70518-2153-02021-02-19Clindamycin Hydrochloride Capsules, USP
70518-2153-02021-02-19Clindamycin Hydrochloride Capsules, USP
70518-2153-02021-02-19Clindamycin Hydrochloride Capsules, USP
70518-2153-12021-02-19Clindamycin Hydrochloride Capsules, USP
70518-2153-12021-02-19Clindamycin Hydrochloride Capsules, USP
70518-2153-12021-02-19Clindamycin Hydrochloride Capsules, USP
70518-2153-12021-02-19Clindamycin Hydrochloride Capsules, USP
70518-2153-22021-02-19Clindamycin Hydrochloride Capsules, USP
70518-2153-22021-02-19Clindamycin Hydrochloride Capsules, USP
70518-2153-22021-02-19Clindamycin Hydrochloride Capsules, USP
70518-2153-22021-02-19Clindamycin Hydrochloride Capsules, USP
70518-2153-32021-02-19Clindamycin Hydrochloride Capsules, USP
70518-2153-32021-02-19Clindamycin Hydrochloride Capsules, USP
70518-2153-32021-02-19Clindamycin Hydrochloride Capsules, USP
70518-2153-32021-02-19Clindamycin Hydrochloride Capsules, USP
70518-2153-02021-01-29Clindamycin Hydrochloride Capsules, USP
70518-2153-02021-01-29Clindamycin Hydrochloride Capsules, USP
70518-2153-02021-01-29Clindamycin Hydrochloride Capsules, USP
70518-2153-02021-01-29Clindamycin Hydrochloride Capsules, USP
70518-2153-12021-01-29Clindamycin Hydrochloride Capsules, USP
70518-2153-12021-01-29Clindamycin Hydrochloride Capsules, USP
70518-2153-12021-01-29Clindamycin Hydrochloride Capsules, USP
70518-2153-12021-01-29Clindamycin Hydrochloride Capsules, USP
70518-2153-22021-01-29Clindamycin Hydrochloride Capsules, USP
70518-2153-22021-01-29Clindamycin Hydrochloride Capsules, USP
70518-2153-22021-01-29Clindamycin Hydrochloride Capsules, USP
70518-2153-22021-01-29Clindamycin Hydrochloride Capsules, USP
70518-2153-32021-01-29Clindamycin Hydrochloride Capsules, USP
70518-2153-32021-01-29Clindamycin Hydrochloride Capsules, USP
70518-2153-32021-01-29Clindamycin Hydrochloride Capsules, USP
70518-2153-32021-01-29Clindamycin 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEREMEDYREPACK INC.f4c4fce0-0472-45a3-b4c6-192d97ca18182026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
ndc (package): 70518-2153-2
ndc (product): 70518-2153
ndc11 (package): 70518215302
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.8e3c9cf6-ab39-4fb5-94e3-232880c477002026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.de7001d1-8b83-4f8b-8e50-c076910214562026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepack5f6a85c5-dca3-49b1-a029-3818a41d49bf2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDESt. Mary's Medical Park Pharmacyafeb96ed-7c2e-72d3-e053-2995a90a4ed32026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEMicro Labs Limited9b9f898f-6a91-44f8-9508-f9ddfaad27bc2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.bde81d4b-ad21-cc09-e053-2995a90a8c012026-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.ba9bd5cd-036b-4b0c-e053-2a95a90a332e2026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDERedPharm Drug, Inc.a2f6fa76-a114-4104-e053-2a95a90a9e0b2026-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDENorthwind Health Company, LLCf6f5c8b2-83a1-5362-e053-6394a90aaaad2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepackcd2ca915-5672-440d-a14e-b4d3b6a522f32025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEDIRECT RXc3f35f80-e4ae-95f5-e053-2995a90a1b642025-07-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEQuality Care Products, LLC1d562ae9-5a9a-4fed-8cc7-3f30fb40f9572024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepackbea7de4c-c077-4535-96a0-f6b319120b0b2024-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.b2bd8402-c887-5bfd-e053-2a95a90a15d92024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEAdvanced Rx of Tennessee, LLC1d760cb7-d166-6707-e063-6394a90a88502024-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.9e68cb17-73d9-8a00-e053-2995a90a517f2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.9fe44bdd-eb59-4b55-e053-2995a90a31832024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEAvPAKb2a810f1-c009-e973-e053-2a95a90ad5b02024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEAsclemed USA, Inc.7d3e6ec5-93e9-4ce0-8276-b19aa97eb7722023-09-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402

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
70518-2153-27051821530220 CAPSULE in 1 BLISTER PACK (70518-2153-2) 20 capsule2019-08-120000-00-00NoNoCurrent