Home NDC 67046-085 Clindamycin Hydrochloride
Product NDC 67046-085
11-digit product format 670460085
Labeler code 67046
Product ID 67046-085_9891d1bd-b662-4242-a01e-8151463bbf2d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clindamycin Hydrochloride
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Contract Pharmacy Services-PA
Application ANDA065194
Marketing category ANDA
Marketing start 2010-07-02
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]
NDC exclude flag E
Listing certified through 2017-12-31
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 3 · 132 matching rows.
View current auxiliary records. · View the auxiliary file history.
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67046-085-10 Clindamycin Hydrochloride 10 in 1 BLISTER PACK CAPSULE, GELATIN COATED 10 1 67046-085-20 Clindamycin Hydrochloride 20 in 1 BLISTER PACK CAPSULE, GELATIN COATED 20 1 67046-085-21 Clindamycin Hydrochloride 21 in 1 BLISTER PACK CAPSULE, GELATIN COATED 21 1 67046-085-28 Clindamycin Hydrochloride 28 in 1 BLISTER PACK CAPSULE, GELATIN COATED 28 1 67046-085-30 Clindamycin Hydrochloride 30 in 1 BLISTER PACK CAPSULE, GELATIN COATED 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLINDAMYCIN HYDROCHLORIDE ACTIVE INGREDIENT T20OQ1YN1W CLINDAMYCIN HYDROCHLORIDE CAPSULE, GELATIN COATED [CONTRACT PHARMACY SERVICES-PA] 1 CLINDAMYCIN ACTIVE MOIETY 3U02EL437C CLINDAMYCIN HYDROCHLORIDE CAPSULE, GELATIN COATED [CONTRACT PHARMACY SERVICES-PA] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CLINDAMYCIN HYDROCHLORIDE CAPSULE, GELATIN COATED [CONTRACT PHARMACY SERVICES-PA] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CLINDAMYCIN HYDROCHLORIDE CAPSULE, GELATIN COATED [CONTRACT PHARMACY SERVICES-PA] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L CLINDAMYCIN HYDROCHLORIDE CAPSULE, GELATIN COATED [CONTRACT PHARMACY SERVICES-PA] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CLINDAMYCIN HYDROCHLORIDE CAPSULE, GELATIN COATED [CONTRACT PHARMACY SERVICES-PA] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLINDAMYCIN HYDROCHLORIDE CAPSULE, GELATIN COATED [CONTRACT PHARMACY SERVICES-PA] 1 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ CLINDAMYCIN HYDROCHLORIDE CAPSULE, GELATIN COATED [CONTRACT PHARMACY SERVICES-PA] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLINDAMYCIN HYDROCHLORIDE CAPSULE, GELATIN COATED [CONTRACT PHARMACY SERVICES-PA] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67046-085 CLINDAMYCIN HYDROCHLORIDE CAPSULE, GELATIN COATED [CONTRACT PHARMACY SERVICES-PA] 1 Legacy NDC, 5 package rows 20100729_9891d1bd-b662-4242-a01e-8151463bbf2d.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 Status 67046-085-10 67046008510 10 in 1 BLISTER PACK Historical 67046-085-20 67046008520 20 in 1 BLISTER PACK Historical 67046-085-21 67046008521 21 in 1 BLISTER PACK Historical 67046-085-28 67046008528 28 in 1 BLISTER PACK Historical 67046-085-30 67046008530 30 in 1 BLISTER PACK Historical