Home NDC 71335-2623 Clindamycin Hydrochloride
Product NDC 71335-2623
11-digit product format 713352623
Labeler code 71335
Product ID 71335-2623_6717d1aa-fd69-427d-b0d5-9b9b1ed2e311
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clindamycin Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA216957
Marketing category ANDA
Marketing start 2023-03-10
Substance CLINDAMYCIN HYDROCHLORIDE
Active strength 150 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 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 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 · 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 A216957-001 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2023-03-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 A216957-002 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2023-03-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 A216957-003 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2023-03-10 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 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 Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLINDAMYCIN HYDROCHLORIDE 150 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 197518 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 71335-2623-0 Clindamycin Hydrochloride 40 in 1 BOTTLE CAPSULE 40 1 71335-2623-1 Clindamycin Hydrochloride 12 in 1 BOTTLE CAPSULE 12 1 71335-2623-2 Clindamycin Hydrochloride 28 in 1 BOTTLE CAPSULE 28 1 71335-2623-3 Clindamycin Hydrochloride 42 in 1 BOTTLE CAPSULE 42 1 71335-2623-4 Clindamycin Hydrochloride 60 in 1 BOTTLE CAPSULE 60 1 71335-2623-5 Clindamycin Hydrochloride 30 in 1 BOTTLE CAPSULE 30 1 71335-2623-6 Clindamycin Hydrochloride 21 in 1 BOTTLE CAPSULE 21 1 71335-2623-7 Clindamycin Hydrochloride 4 in 1 BOTTLE CAPSULE 4 1 71335-2623-8 Clindamycin Hydrochloride 56 in 1 BOTTLE CAPSULE 56 1 71335-2623-9 Clindamycin Hydrochloride 20 in 1 BOTTLE CAPSULE 20 1
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 71335-2623-0 71335262300 40 CAPSULE in 1 BOTTLE (71335-2623-0) 40 capsule 2025-06-03 No No Current 71335-2623-1 71335262301 12 CAPSULE in 1 BOTTLE (71335-2623-1) 12 capsule 2025-06-03 No No Current 71335-2623-2 71335262302 28 CAPSULE in 1 BOTTLE (71335-2623-2) 28 capsule 2025-06-03 No No Current 71335-2623-3 71335262303 42 CAPSULE in 1 BOTTLE (71335-2623-3) 42 capsule 2025-06-03 No No Current 71335-2623-4 71335262304 60 CAPSULE in 1 BOTTLE (71335-2623-4) 60 capsule 2025-06-03 No No Current 71335-2623-5 71335262305 30 CAPSULE in 1 BOTTLE (71335-2623-5) 30 capsule 2025-06-03 No No Current 71335-2623-6 71335262306 21 CAPSULE in 1 BOTTLE (71335-2623-6) 21 capsule 2025-06-03 No No Current 71335-2623-7 71335262307 4 CAPSULE in 1 BOTTLE (71335-2623-7) 4 capsule 2025-06-03 No No Current 71335-2623-8 71335262308 56 CAPSULE in 1 BOTTLE (71335-2623-8) 56 capsule 2025-06-03 No No Current 71335-2623-9 71335262309 20 CAPSULE in 1 BOTTLE (71335-2623-9) 20 capsule 2025-06-03 No No Current