Home NDC 68462-486 clindamycin and benzoyl peroxide
Product NDC 68462-486
11-digit product format 684620486
Labeler code 68462
Product ID 68462-486_03e34592-8f1e-49cd-8a20-824d2b18b4b5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clindamycin and benzoyl peroxide
Dosage form GEL
Route TOPICAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA209252
Marketing category ANDA
Marketing start 2019-03-14
Substance BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
Active strength 50; 10 mg/g; mg/g
Pharmacologic classes Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 5%;EQ 1% BASE GEL / TOPICAL AB RS 2019-03-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209252-001 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 2 · 41 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 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB RS 2019-03-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB RS 2019-03-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB RS 2019-03-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB RS 2019-03-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB RS 2019-03-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB RS 2019-03-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB RS 2019-03-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB RS 2019-03-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB RS 2019-03-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB RS 2019-03-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB RS 2019-03-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB RS 2019-03-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB RS 2019-03-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB RS 2019-03-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB 2019-03-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB 2019-03-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB 2019-03-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB 2019-03-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB 2019-03-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB 2019-03-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB 2019-03-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB 2019-03-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB 2019-03-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB 2019-03-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB 2019-03-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB 2019-03-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB 2019-03-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB RS 2019-03-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB RS 2019-03-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB RS 2019-03-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB RS 2019-03-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB RS 2019-03-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB RS 2019-03-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB RS 2019-03-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB RS 2019-03-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB 2019-03-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB 2019-03-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB 2019-03-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB 2019-03-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209252-001 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 5%;EQ 1% BASE GEL / TOPICAL AB 2019-03-14 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base clindamycin and benzoyl peroxide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLINDAMYCIN PHOSPHATE 50 mg/g BENZOYL PEROXIDE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W9WZN9A0GM Internal UNII lookup EH6D7113I8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 358917 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 68462-486-19 clindamycin and benzoyl peroxide 25 g in 1 JAR GEL 25 6 68462-486-19 clindamycin and benzoyl peroxide 1 in 1 CARTON GEL 1 6 68462-486-24 clindamycin and benzoyl peroxide 35 g in 1 JAR GEL 35 6 68462-486-24 clindamycin and benzoyl peroxide 1 in 1 CARTON GEL 1 6 68462-486-27 clindamycin and benzoyl peroxide 1 in 1 CARTON GEL 1 6 68462-486-27 clindamycin and benzoyl peroxide 50 g in 1 JAR GEL 50 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-486 CLINDAMYCIN AND BENZOYL PEROXIDE GEL [GLENMARK PHARMACEUTICALS INC., USA] 5 Current NDC, Legacy NDC, 6 package rows 20240103_76795d1b-e1f2-4d1d-b42a-f1d4448c63c0.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 · 2 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 68462-486-19 68462048619 1 JAR in 1 CARTON (68462-486-19) / 25 g in 1 JAR 1 jar 2019-03-14 0000-00-00 No No Current 68462-486-24 68462048624 1 JAR in 1 CARTON (68462-486-24) / 35 g in 1 JAR 1 jar 2019-05-07 0000-00-00 No No Current 68462-486-27 68462048627 1 JAR in 1 CARTON (68462-486-27) / 50 g in 1 JAR 1 jar 2019-03-14 0000-00-00 No No Current