Clindamycin in 5 percent Dextrose

Product NDC
0143-9269
11-digit product format
001439269
Labeler code
0143
Product ID
0143-9269_0dbb7c39-4e79-4a6a-9f25-d4920b2e6562
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin in 5 percent Dextrose
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA214401
Marketing category
ANDA
Marketing start
2024-06-12
Substance
CLINDAMYCIN
Active strength
18 mg/mL
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

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
A214401-001CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%CLINDAMYCIN PHOSPHATEEQ 6MG BASE/MLINJECTABLE / INJECTIONAP2023-04-05
A214401-002CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%CLINDAMYCIN PHOSPHATEEQ 12MG BASE/MLINJECTABLE / INJECTIONAP2023-04-05
A214401-003CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%CLINDAMYCIN PHOSPHATEEQ 18MG BASE/MLINJECTABLE / INJECTIONAP2023-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214401-001AP
A214401-002AP
A214401-003AP

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 · 69 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214401-001CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 6MG BASE/MLINJECTABLE / INJECTIONAP2023-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214401-002CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 12MG BASE/MLINJECTABLE / INJECTIONAP2023-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214401-003CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 18MG BASE/MLINJECTABLE / INJECTIONAP2023-04-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214401-001CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 6MG BASE/MLINJECTABLE / INJECTIONAP2023-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214401-002CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 12MG BASE/MLINJECTABLE / INJECTIONAP2023-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214401-003CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 18MG BASE/MLINJECTABLE / INJECTIONAP2023-04-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A214401-001CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 6MG BASE/MLINJECTABLE / INJECTIONAP2023-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214401-002CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 12MG BASE/MLINJECTABLE / INJECTIONAP2023-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214401-003CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 18MG BASE/MLINJECTABLE / INJECTIONAP2023-04-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214401-001CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 6MG BASE/MLINJECTABLE / INJECTIONAP2023-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214401-002CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 12MG BASE/MLINJECTABLE / INJECTIONAP2023-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214401-003CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 18MG BASE/MLINJECTABLE / INJECTIONAP2023-04-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214401-001CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 6MG BASE/MLINJECTABLE / INJECTIONAP2023-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214401-002CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 12MG BASE/MLINJECTABLE / INJECTIONAP2023-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214401-003CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 18MG BASE/MLINJECTABLE / INJECTIONAP2023-04-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214401-001CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 6MG BASE/MLINJECTABLE / INJECTIONAP2023-04-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214401-002CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 12MG BASE/MLINJECTABLE / INJECTIONAP2023-04-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214401-003CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 18MG BASE/MLINJECTABLE / INJECTIONAP2023-04-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214401-001CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 6MG BASE/MLINJECTABLE / INJECTIONAP2023-04-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214401-002CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 12MG BASE/MLINJECTABLE / INJECTIONAP2023-04-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214401-003CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 18MG BASE/MLINJECTABLE / INJECTIONAP2023-04-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214401-001CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 6MG BASE/MLINJECTABLE / INJECTIONAP2023-04-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214401-002CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 12MG BASE/MLINJECTABLE / INJECTIONAP2023-04-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214401-003CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 18MG BASE/MLINJECTABLE / INJECTIONAP2023-04-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214401-001CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 6MG BASE/MLINJECTABLE / INJECTIONAP2023-04-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214401-002CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 12MG BASE/MLINJECTABLE / INJECTIONAP2023-04-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214401-003CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 18MG BASE/MLINJECTABLE / INJECTIONAP2023-04-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214401-001CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 6MG BASE/MLINJECTABLE / INJECTIONAP2023-04-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A214401-002CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 12MG BASE/MLINJECTABLE / INJECTIONAP2023-04-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A214401-003CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 18MG BASE/MLINJECTABLE / INJECTIONAP2023-04-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214401-001CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 6MG BASE/MLINJECTABLE / INJECTIONAP2023-04-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214401-002CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 12MG BASE/MLINJECTABLE / INJECTIONAP2023-04-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214401-003CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 18MG BASE/MLINJECTABLE / INJECTIONAP2023-04-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214401-001CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 6MG BASE/MLINJECTABLE / INJECTIONAP2023-04-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214401-002CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 12MG BASE/MLINJECTABLE / INJECTIONAP2023-04-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214401-003CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 18MG BASE/MLINJECTABLE / INJECTIONAP2023-04-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214401-001CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 6MG BASE/MLINJECTABLE / INJECTIONAP2023-04-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214401-002CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 12MG BASE/MLINJECTABLE / INJECTIONAP2023-04-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214401-003CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 18MG BASE/MLINJECTABLE / INJECTIONAP2023-04-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214401-001CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%EQ 6MG BASE/MLINJECTABLE / INJECTIONAP2023-04-058072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 69 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214401-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214401-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214401-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214401-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214401-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214401-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214401-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214401-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214401-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214401-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214401-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214401-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214401-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214401-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214401-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214401-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214401-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214401-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214401-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214401-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214401-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214401-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214401-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214401-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214401-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214401-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214401-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214401-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214401-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214401-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214401-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214401-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214401-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214401-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214401-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214401-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214401-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214401-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214401-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214401-001AP18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Clindamycin in 5 percent Dextrose
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN18 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3U02EL437CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309335Internal RxNorm lookup
309336Internal RxNorm lookup
309339Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8b452032-abed-495b-b518-15623e9850a3Available 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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
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
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
5ce6ce33-4f2b-3ce0-757d-e520013280cfProduct name520180719
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
b92a26f1-6926-4817-be73-e26ab4c2146fProduct name120170602
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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
0143-9269-01Clindamycin in 5 percent Dextrose1 in 1 CARTONINJECTION, SOLUTION14
0143-9269-01Clindamycin in 5 percent Dextrose50 mL in 1 VIALINJECTION, SOLUTION504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9269-01ML - Milliliter0143-92699506fdc4-8474-4acb-b4f6-96b8197c618912024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9269CLINDAMYCIN IN 5 PERCENT DEXTROSE (CLINDAMYCIN IN PERCENT DEXTROSE) INJECTION, SOLUTION CLINDAMYCIN IN 5 PERCENT DEXTROSE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]4Current NDC, 2 package rows20240719_8b452032-abed-495b-b518-15623e9850a3.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clindamycin in 5 percent DextroseCLINDAMYCIN IN PERCENT DEXTROSEHikma Pharmaceuticals USA Inc.8b452032-abed-495b-b518-15623e9850a32024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214401
application number: ANDA214401
ndc (product): 0143-9269

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309339clindamycin 300 MG in 50 ML InjectionPSN8b452032-abed-495b-b518-15623e9850a34
309335clindamycin 600 MG in 50 ML InjectionPSN8b452032-abed-495b-b518-15623e9850a34
309336clindamycin 900 MG in 50 ML InjectionPSN8b452032-abed-495b-b518-15623e9850a34
30933550 ML clindamycin 12 MG/ML InjectionSCD8b452032-abed-495b-b518-15623e9850a34
30933650 ML clindamycin 18 MG/ML InjectionSCD8b452032-abed-495b-b518-15623e9850a34
30933950 ML clindamycin 6 MG/ML InjectionSCD8b452032-abed-495b-b518-15623e9850a34
309339clindamycin (as clindamycin phosphate) 300 MG per 50 ML InjectionSY8b452032-abed-495b-b518-15623e9850a34
309335clindamycin (as clindamycin phosphate) 600 MG per 50 ML InjectionSY8b452032-abed-495b-b518-15623e9850a34
309336clindamycin (as clindamycin phosphate) 900 MG per 50 ML InjectionSY8b452032-abed-495b-b518-15623e9850a34
309335clindamycin 600 MG per 50 ML InjectionSY8b452032-abed-495b-b518-15623e9850a34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0143-9269-01001439269011 VIAL in 1 CARTON (0143-9269-01) / 50 mL in 1 VIAL1 vial2024-06-12NoNoCurrent