Home NDC 68071-4335 Clindamycin hydrochloride
Product NDC 68071-4335
11-digit product format 680714335
Labeler code 68071
Product ID 68071-4335_1a551f3b-f4a5-63c5-e063-6394a90a6eb0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clindamycin hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA065061
Marketing category ANDA
Marketing start 2001-03-23
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 2026-12-31
Current FDA listing Yes 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 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A065061-001 CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2001-02-02 A065061-002 CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2001-02-02
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 · 86 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 A065061-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2001-02-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065061-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2001-02-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065061-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2001-02-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065061-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2001-02-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065061-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2001-02-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065061-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2001-02-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065061-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2001-02-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065061-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2001-02-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065061-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2001-02-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065061-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2001-02-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065061-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2001-02-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065061-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2001-02-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065061-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2001-02-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065061-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2001-02-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065061-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2001-02-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065061-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2001-02-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065061-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2001-02-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065061-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2001-02-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065061-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2001-02-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065061-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2001-02-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065061-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2001-02-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065061-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2001-02-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065061-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2001-02-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065061-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2001-02-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065061-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2001-02-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065061-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2001-02-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065061-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2001-02-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065061-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2001-02-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065061-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2001-02-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065061-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2001-02-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065061-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2001-02-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065061-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2001-02-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065061-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2001-02-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065061-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2001-02-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065061-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2001-02-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065061-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2001-02-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065061-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2001-02-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065061-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2001-02-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065061-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2001-02-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065061-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2001-02-02 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 2026-12-31 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 68071-4335-0 2024-06-07 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only 68071-4335-1 2024-06-07 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only 68071-4335-2 2024-06-07 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only 68071-4335-3 2024-06-07 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only 68071-4335-4 2024-06-07 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only 68071-4335-6 2024-06-07 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only 68071-4335-7 2024-06-07 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only 68071-4335-8 2024-06-07 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only 68071-4335-0 2023-01-30 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only 68071-4335-1 2023-01-30 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only 68071-4335-2 2023-01-30 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only 68071-4335-3 2023-01-30 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only 68071-4335-4 2023-01-30 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only 68071-4335-6 2023-01-30 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only 68071-4335-7 2023-01-30 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only 68071-4335-8 2023-01-30 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only 68071-4335-6 2021-02-16 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only 68071-4335-7 2021-02-16 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only 68071-4335-6 2021-01-29 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only 68071-4335-7 2021-01-29 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-4335-0 Clindamycin hydrochloride 4 in 1 BOTTLE CAPSULE 4 6 68071-4335-1 Clindamycin hydrochloride 21 in 1 BOTTLE CAPSULE 21 6 68071-4335-2 Clindamycin hydrochloride 20 in 1 BOTTLE CAPSULE 20 6 68071-4335-3 Clindamycin hydrochloride 30 in 1 BOTTLE CAPSULE 30 6 68071-4335-4 Clindamycin hydrochloride 40 in 1 BOTTLE CAPSULE 40 6 68071-4335-6 Clindamycin hydrochloride 60 in 1 BOTTLE CAPSULE 60 6 68071-4335-7 Clindamycin hydrochloride 42 in 1 BOTTLE CAPSULE 42 6 68071-4335-8 Clindamycin hydrochloride 28 in 1 BOTTLE CAPSULE 28 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-4335 CLINDAMYCIN HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS,INC.] 6 Current NDC, Legacy NDC, 8 package rows 20240608_678912ff-a0c1-171b-e053-2991aa0ad128.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 2 of 2 · 21 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 68071-4335-0 68071433500 4 CAPSULE in 1 BOTTLE (68071-4335-0) 4 capsule 2018-03-16 0000-00-00 No No Current 68071-4335-1 68071433501 21 CAPSULE in 1 BOTTLE (68071-4335-1) 21 capsule 2018-03-16 0000-00-00 No No Current 68071-4335-2 68071433502 20 CAPSULE in 1 BOTTLE (68071-4335-2) 20 capsule 2018-03-16 0000-00-00 No No Current 68071-4335-3 68071433503 30 CAPSULE in 1 BOTTLE (68071-4335-3) 30 capsule 2018-03-16 0000-00-00 No No Current 68071-4335-4 68071433504 40 CAPSULE in 1 BOTTLE (68071-4335-4) 40 capsule 2018-03-16 0000-00-00 No No Current 68071-4335-6 68071433506 60 CAPSULE in 1 BOTTLE (68071-4335-6) 60 capsule 2018-03-16 0000-00-00 No No Current 68071-4335-7 68071433507 42 CAPSULE in 1 BOTTLE (68071-4335-7) 42 capsule 2018-03-16 0000-00-00 No No Current 68071-4335-8 68071433508 28 CAPSULE in 1 BOTTLE (68071-4335-8) 28 capsule 2018-03-16 0000-00-00 No No Current