Home NDC 85766-028 Clindamycin Hydrochloride
Product NDC 85766-028
11-digit product format 857660028
Labeler code 85766
Product ID 85766-028_4a16a979-a5d0-bafe-e063-6294a90adc9e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clindamycin Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Sportpharm LLC
Application ANDA216957
Marketing category ANDA
Marketing start 2023-03-10
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A216957-001 CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2023-03-10 A216957-002 CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2023-03-10 A216957-003 CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2023-03-10
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 · 75 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 2026-09-14 22:38:34 2026-08 A216957-001 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2023-03-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216957-002 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2023-03-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216957-003 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2023-03-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216957-001 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2023-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216957-002 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2023-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216957-003 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2023-03-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216957-001 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2023-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216957-002 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2023-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216957-003 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2023-03-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216957-001 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2023-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216957-002 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2023-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216957-003 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2023-03-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216957-001 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2023-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216957-002 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2023-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216957-003 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2023-03-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216957-001 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2023-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216957-002 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2023-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216957-003 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2023-03-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216957-001 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2023-03-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216957-002 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2023-03-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216957-003 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2023-03-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216957-001 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2023-03-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216957-002 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2023-03-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216957-003 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2023-03-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216957-001 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2023-03-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216957-002 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2023-03-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216957-003 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2023-03-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216957-001 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2023-03-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216957-002 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2023-03-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216957-003 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2023-03-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216957-001 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2023-03-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216957-002 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2023-03-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216957-003 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2023-03-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216957-001 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2023-03-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216957-002 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2023-03-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216957-003 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2023-03-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216957-001 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2023-03-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216957-002 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2023-03-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216957-003 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2023-03-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216957-001 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2023-03-10 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 75 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 Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLINDAMYCIN HYDROCHLORIDE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination T20OQ1YN1W Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 284215 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 85766-028-01 Clindamycin Hydrochloride 100 in 1 BOTTLE CAPSULE 100 2 85766-028-12 Clindamycin Hydrochloride 12 in 1 BOTTLE CAPSULE 12 2 85766-028-16 Clindamycin Hydrochloride 16 in 1 BOTTLE CAPSULE 16 2 85766-028-20 Clindamycin Hydrochloride 20 in 1 BOTTLE CAPSULE 20 2 85766-028-30 Clindamycin Hydrochloride 30 in 1 BOTTLE CAPSULE 30 2 85766-028-60 Clindamycin Hydrochloride 60 in 1 BOTTLE CAPSULE 60 2 85766-028-90 Clindamycin Hydrochloride 90 in 1 BOTTLE CAPSULE 90 2
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 2 of 2 · 22 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 85766-028-01 85766002801 100 CAPSULE in 1 BOTTLE (85766-028-01) 100 capsule 2025-08-07 No No Current 85766-028-12 85766002812 12 CAPSULE in 1 BOTTLE (85766-028-12) 12 capsule 2025-08-07 No No Current 85766-028-16 85766002816 16 CAPSULE in 1 BOTTLE (85766-028-16) 16 capsule 2025-08-07 No No Current 85766-028-20 85766002820 20 CAPSULE in 1 BOTTLE (85766-028-20) 20 capsule 2025-08-07 No No Current 85766-028-30 85766002830 30 CAPSULE in 1 BOTTLE (85766-028-30) 30 capsule 2025-08-07 No No Current 85766-028-60 85766002860 60 CAPSULE in 1 BOTTLE (85766-028-60) 60 capsule 2025-08-07 No No Current 85766-028-90 85766002890 90 CAPSULE in 1 BOTTLE (85766-028-90) 90 capsule 2025-08-07 No No Current