Home NDC 0143-9267 Clindamycin in 5 percent Dextrose
Product NDC 0143-9267
11-digit product format 001439267
Labeler code 0143
Product ID 0143-9267_0dbb7c39-4e79-4a6a-9f25-d4920b2e6562
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clindamycin in 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 6 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 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214401-001 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% CLINDAMYCIN PHOSPHATE EQ 6MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 A214401-002 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% CLINDAMYCIN PHOSPHATE EQ 12MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 A214401-003 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% CLINDAMYCIN PHOSPHATE EQ 18MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 78 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A214401-001 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 6MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 A214401-002 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 12MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 A214401-003 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 18MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 c2088c7a36db…2026-09-14 22:38:34 2026-08 A214401-001 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 6MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214401-002 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 12MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214401-003 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 18MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214401-001 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 6MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214401-002 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 12MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214401-003 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 18MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214401-001 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 6MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214401-002 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 12MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214401-003 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 18MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214401-001 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 6MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214401-002 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 12MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214401-003 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 18MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214401-001 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 6MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214401-002 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 12MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214401-003 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 18MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214401-001 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 6MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214401-002 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 12MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214401-003 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 18MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214401-001 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 6MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214401-002 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 12MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214401-003 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 18MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214401-001 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 6MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214401-002 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 12MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214401-003 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 18MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214401-001 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 6MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214401-002 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 12MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214401-003 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 18MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214401-001 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 6MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214401-002 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 12MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214401-003 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 18MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214401-001 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 6MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214401-002 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 12MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214401-003 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 18MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214401-001 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 6MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214401-002 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 12MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214401-003 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 18MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214401-001 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% EQ 6MG BASE/ML INJECTABLE / INJECTION AP 2023-04-05 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 78 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Clindamycin in 5 percent Dextrose
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLINDAMYCIN 6 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3U02EL437C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309335 Internal RxNorm lookup 309336 Internal RxNorm lookup 309339 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0143-9267-01 Clindamycin in 5 percent Dextrose 50 mL in 1 VIAL INJECTION, SOLUTION 50 4 0143-9267-01 Clindamycin in 5 percent Dextrose 1 in 1 CARTON INJECTION, SOLUTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9267 CLINDAMYCIN IN 5 PERCENT DEXTROSE (CLINDAMYCIN IN PERCENT DEXTROSE) INJECTION, SOLUTION CLINDAMYCIN IN 5 PERCENT DEXTROSE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 4 Current NDC, 2 package rows 20240719_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0143-9267-01 00143926701 1 VIAL in 1 CARTON (0143-9267-01) / 50 mL in 1 VIAL 1 vial 2024-06-12 No No Current