Clindamycin

Product NDC
0404-9838
11-digit product format
004049838
Labeler code
0404
Product ID
0404-9838_818d5172-0214-4204-b2e6-6266ce15e8e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Phosphate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
ANDA090108
Marketing category
ANDA
Marketing start
2022-01-09
Substance
CLINDAMYCIN PHOSPHATE
Active strength
150 mg/mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0404-98380404-9838-02DDiscontinued by firm2026-08-03
excluded packagepackage0404-98380404-9838-06DDiscontinued by firm2026-08-03

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090108-001CLINDAMYCIN PHOSPHATECLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090108-001AP

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-303f01610625f2…
2019-09-15 20:21 UTC2019-09A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090108-001CLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP2011-09-30cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090108-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090108-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090108-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090108-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090108-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090108-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090108-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090108-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090108-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090108-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090108-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090108-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090108-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090108-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090108-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090108-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090108-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090108-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090108-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090108-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090108-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A090108-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090108-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090108-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090108-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A090108-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090108-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090108-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090108-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090108-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090108-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090108-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090108-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090108-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090108-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090108-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090108-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090108-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090108-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090108-001AP1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Clindamycin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN PHOSPHATE150 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EH6D7113I8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1737244Internal RxNorm lookup
1737578Internal RxNorm lookup
1737581Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8a4e2ba4-90e6-48e8-a943-0c5d3f169780Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-9838-02Clindamycin2 mL in 1 VIALINJECTION, SOLUTION26
0404-9838-02Clindamycin1 in 1 BAGINJECTION, SOLUTION16
0404-9838-04Clindamycin4 mL in 1 VIALINJECTION, SOLUTION46
0404-9838-04Clindamycin1 in 1 BAGINJECTION, SOLUTION16
0404-9838-06Clindamycin1 in 1 BAGINJECTION, SOLUTION16
0404-9838-06Clindamycin6 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION66

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9838CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [HENRY SCHEIN, INC.]5Current NDC, Legacy NDC, 6 package rows20250410_8a4e2ba4-90e6-48e8-a943-0c5d3f169780.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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClindamycinCLINDAMYCIN PHOSPHATEHenry Schein, Inc.8a4e2ba4-90e6-48e8-a943-0c5d3f1697802026-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090108
application number: ANDA090108
ndc (product): 0404-9838
ClindamycinCLINDAMYCIN PHOSPHATESagent Pharmaceuticals7a6967b3-5563-4bed-9eee-d400f800e7992024-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090108
application number: ANDA090108
ClindamycinCLINDAMYCIN PHOSPHATEMedical Purchasing Solutions, LLC9e500a08-0339-eb6b-e053-2a95a90a130c2023-05-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090108
application number: ANDA090108
ClindamycinCLINDAMYCIN PHOSPHATEMedical Purchasing Solutions, LLC9e4fc2d5-985a-3734-e053-2995a90aef5b2023-05-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090108
application number: ANDA090108
ClindamycinCLINDAMYCIN PHOSPHATEMedical Purchasing Solutions, LLCdc8b8a09-3eed-1998-e053-2995a90a2f602023-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090108
application number: ANDA090108

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737244clindamycin 300 MG in 2 ML InjectionPSN8a4e2ba4-90e6-48e8-a943-0c5d3f1697806
1737578clindamycin 600 MG in 4 ML InjectionPSN8a4e2ba4-90e6-48e8-a943-0c5d3f1697806
1737581clindamycin 900 MG in 6 ML InjectionPSN8a4e2ba4-90e6-48e8-a943-0c5d3f1697806
17372442 ML clindamycin 150 MG/ML InjectionSCD8a4e2ba4-90e6-48e8-a943-0c5d3f1697806
17375784 ML clindamycin 150 MG/ML InjectionSCD8a4e2ba4-90e6-48e8-a943-0c5d3f1697806
17375816 ML clindamycin 150 MG/ML InjectionSCD8a4e2ba4-90e6-48e8-a943-0c5d3f1697806
1737244clindamycin (as clindamycin phosphate) 300 MG per 2 ML InjectionSY8a4e2ba4-90e6-48e8-a943-0c5d3f1697806
1737578clindamycin (as clindamycin phosphate) 600 MG per 4 ML InjectionSY8a4e2ba4-90e6-48e8-a943-0c5d3f1697806
1737581clindamycin (as clindamycin phosphate) 900 MG per 6 ML InjectionSY8a4e2ba4-90e6-48e8-a943-0c5d3f1697806
1737244clindamycin 300 MG per 2 ML InjectionSY8a4e2ba4-90e6-48e8-a943-0c5d3f1697806
1737578clindamycin 600 MG per 4 ML InjectionSY8a4e2ba4-90e6-48e8-a943-0c5d3f1697806
1737581clindamycin 900 MG per 6 ML InjectionSY8a4e2ba4-90e6-48e8-a943-0c5d3f1697806

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-9838-02004049838021 VIAL in 1 BAG (0404-9838-02) > 2 mL in 1 VIAL1 vial2022-01-090000-00-00NoNoCurrent
0404-9838-04004049838041 VIAL in 1 BAG (0404-9838-04) / 4 mL in 1 VIAL1 vial2022-01-092026-12-31NoNoCurrent
0404-9838-06004049838061 VIAL, SINGLE-DOSE in 1 BAG (0404-9838-06) > 6 mL in 1 VIAL, SINGLE-DOSE2022-01-090000-00-00NoNoCurrent