Home NDC 69238-2121 clindamycin hydrochloride
Product NDC 69238-2121
11-digit product format 692382121
Labeler code 69238
Product ID 69238-2121_f118e287-5acc-4a8b-bcf0-01436de5bdf9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clindamycin hydrochloride
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA065194
Marketing category ANDA
Marketing start 2022-04-25
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 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065194-001 CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2004-03-22 A065194-002 CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2004-03-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 A065194-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2004-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065194-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2004-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065194-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2004-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065194-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2004-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065194-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2004-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065194-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2004-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065194-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2004-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065194-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2004-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065194-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2004-03-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065194-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2004-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065194-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2004-03-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065194-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2004-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065194-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2004-03-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065194-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2004-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065194-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2004-03-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065194-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2004-03-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065194-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2004-03-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065194-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2004-03-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065194-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2004-03-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065194-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2004-03-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065194-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2004-03-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065194-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2004-03-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065194-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2004-03-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065194-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2004-03-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065194-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2004-03-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065194-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2004-03-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065194-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2004-03-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065194-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2004-03-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065194-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2004-03-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065194-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2004-03-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065194-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2004-03-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065194-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2004-03-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065194-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2004-03-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065194-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2004-03-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065194-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2004-03-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065194-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2004-03-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065194-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2004-03-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065194-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2004-03-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065194-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2004-03-22 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065194-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2004-03-22 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base clindamycin hydrochloride
Listing expiration 2026-12-31 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 69238-2121-3 clindamycin hydrochloride 3 in 1 CARTON CAPSULE, GELATIN COATED 3 17 69238-2121-4 clindamycin hydrochloride 10 in 1 BLISTER PACK CAPSULE, GELATIN COATED 10 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-2121 CLINDAMYCIN HYDROCHLORIDE CAPSULE, GELATIN COATED [AMNEAL PHARMACEUTICALS NY LLC] 17 Current NDC, Legacy NDC, 2 package rows 20231230_e08eea9e-464c-429e-9584-b768f5127767.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 Marketing end Sample Exclude flag Status 69238-2121-3 69238212103 3 BLISTER PACK in 1 CARTON (69238-2121-3) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (69238-2121-4) 3 blister pack 2022-04-25 0000-00-00 No No Current 69238-2121-4 69238212104 10 in 1 BLISTER PACK Historical