Home NDC 0527-1382 Clindamycin Hydrochloride
Product NDC 0527-1382
11-digit product format 005271382
Labeler code 0527
Product ID 0527-1382_cc80896e-4a77-45d4-8625-9ac72e5fbfd2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clindamycin Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA065243
Marketing category ANDA
Marketing start 2005-08-12
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0527-1382-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0527-1382-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0527-1382-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0527-1382-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0527-1382-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0527-1382-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0527-1382-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0527-1382-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0527-1382-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0527-1382-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0527-1382-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0527-1382-01 557ba5c1ecfa…9c80585c8c6e…
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 A065243-001 CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2005-08-12 A065243-002 CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2005-08-12 A065243-003 CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 2005-08-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065243-002 AB
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 4 · 132 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 A065243-001 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2005-08-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 A065243-002 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2005-08-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 A065243-003 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 2005-08-12 c2088c7a36db…2026-09-14 22:38:34 2026-08 A065243-001 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2005-08-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065243-002 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2005-08-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065243-003 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 2005-08-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065243-001 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2005-08-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065243-002 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2005-08-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065243-003 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 2005-08-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065243-001 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2005-08-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065243-002 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2005-08-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065243-003 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 2005-08-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065243-001 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2005-08-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065243-002 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2005-08-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065243-003 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 2005-08-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065243-001 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2005-08-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065243-002 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2005-08-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065243-003 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 2005-08-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065243-001 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2005-08-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065243-002 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2005-08-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065243-003 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 2005-08-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065243-001 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2005-08-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065243-002 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2005-08-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065243-003 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 2005-08-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065243-001 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2005-08-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065243-002 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2005-08-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065243-003 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 2005-08-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065243-001 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2005-08-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065243-002 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2005-08-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065243-003 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 2005-08-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065243-001 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2005-08-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065243-002 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2005-08-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065243-003 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 2005-08-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065243-001 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2005-08-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065243-002 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2005-08-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065243-003 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 2005-08-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065243-001 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2005-08-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065243-002 CLINDAMYCIN HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2005-08-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065243-003 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 2005-08-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065243-001 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2005-08-12 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 56 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLINDAMYCIN HYDROCHLORIDE ACTIVE INGREDIENT T20OQ1YN1W CLINDAMYCIN HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 20 CLINDAMYCIN ACTIVE MOIETY 3U02EL437C CLINDAMYCIN HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 20 ALCOHOL INACTIVE INGREDIENT 3K9958V90M CLINDAMYCIN HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 20 AMMONIA INACTIVE INGREDIENT 5138Q19F1X CLINDAMYCIN HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 20 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 CLINDAMYCIN HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 20 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L CLINDAMYCIN HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 20 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CLINDAMYCIN HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 20 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CLINDAMYCIN HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 20 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S CLINDAMYCIN HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 20 GELATIN INACTIVE INGREDIENT 2G86QN327L CLINDAMYCIN HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 20 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 CLINDAMYCIN HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 20 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CLINDAMYCIN HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 20 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLINDAMYCIN HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 20 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CLINDAMYCIN HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 20 SHELLAC INACTIVE INGREDIENT 46N107B71O CLINDAMYCIN HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 20 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CLINDAMYCIN HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 20 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CLINDAMYCIN HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 20 TALC INACTIVE INGREDIENT 7SEV7J4R1U CLINDAMYCIN HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 20 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLINDAMYCIN HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] 20 CLINDAMYCIN HYDROCHLORIDE ACTIVE INGREDIENT T20OQ1YN1W CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 CLINDAMYCIN ACTIVE MOIETY 3U02EL437C CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 ALCOHOL INACTIVE INGREDIENT 3K9958V90M CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 AMMONIA INACTIVE INGREDIENT 5138Q19F1X CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 GELATIN INACTIVE INGREDIENT 2G86QN327L CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 SHELLAC INACTIVE INGREDIENT 46N107B71O CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 TALC INACTIVE INGREDIENT 7SEV7J4R1U CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14
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 0527-1382-01 00527138201 100 CAPSULE in 1 BOTTLE (0527-1382-01) 100 capsule 2005-08-12 0000-00-00 No No Current