Home NDC 70518-0732 Clindamycin hydrochloride
Product NDC 70518-0732
11-digit product format 705180732
Labeler code 70518
Product ID 70518-0732_a5765f72-3604-3403-e053-2a95a90a8dd0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clindamycin hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA065061
Marketing category ANDA
Marketing start 2017-09-12
Marketing end 0000-00-00
Substance CLINDAMYCIN HYDROCHLORIDE
Active strength 300 mg/1
Pharmacologic classes Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 30 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.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-0732 CLINDAMYCIN HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.] 16 Legacy NDC 20250429_79201363-320a-42f9-84b0-458e585a8a3a.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.