Home NDC 68788-9780 clindamycin phosphate
Product NDC 68788-9780
11-digit product format 687889780
Labeler code 68788
Product ID 68788-9780_1c8469bf-a382-468c-8cf0-ac59fe07f78d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clindamycin phosphate
Dosage form GEL
Route TOPICAL
Labeler Preferred Pharmaceuticals, Inc.
Application ANDA064160
Marketing category ANDA
Marketing start 2012-07-27
Marketing end 0000-00-00
Substance CLINDAMYCIN PHOSPHATE
Active strength 10 mg/g
Pharmacologic classes Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]
NDC exclude flag No
Listing certified through 2020-12-31
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 68788-9780-3 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 68788-9780-3 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 68788-9780-3 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 68788-9780-3 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 68788-9780-3 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 68788-9780-3 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 68788-9780-3 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 68788-9780-3 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 68788-9780-3 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 68788-9780-3 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 68788-9780-3 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 68788-9780-3 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A064160-001 CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A064160-001 AB1
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 · 42 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 2026-08-18 06:07:40 2026-07 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB 2000-01-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB 2000-01-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB 2000-01-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB 2000-01-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB 2000-01-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB 2000-01-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB 2000-01-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB 2000-01-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A064160-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2000-01-28 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 68788-9780-3 2021-02-04 C162847 48780-1 ba0f9c33-1df3-a910-e053-dadaa90a0b85 Clindamycin Phosphate Topical Solution USP, 1%, Clindamycin Phosphate Gel USP, 1%, Clindamycin Phosphate Lotion (Clindamycin Phosphate Topical Suspension USP, 1%) 68788-9780-3 2021-01-29 C162847 48780-1 ba0f9c33-1df3-a910-e053-dadaa90a0b85 Clindamycin Phosphate Topical Solution USP, 1%, Clindamycin Phosphate Gel USP, 1%, Clindamycin Phosphate Lotion (Clindamycin Phosphate Topical Suspension USP, 1%)
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLINDAMYCIN PHOSPHATE ACTIVE INGREDIENT EH6D7113I8 CLINDAMYCIN PHOSPHATE GEL [PREFERRED PHARMACEUTICALS, INC.] 2 CLINDAMYCIN ACTIVE MOIETY 3U02EL437C CLINDAMYCIN PHOSPHATE GEL [PREFERRED PHARMACEUTICALS, INC.] 2 ALLANTOIN INACTIVE INGREDIENT 344S277G0Z CLINDAMYCIN PHOSPHATE GEL [PREFERRED PHARMACEUTICALS, INC.] 2 CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT HHT01ZNK31 CLINDAMYCIN PHOSPHATE GEL [PREFERRED PHARMACEUTICALS, INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T CLINDAMYCIN PHOSPHATE GEL [PREFERRED PHARMACEUTICALS, INC.] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ CLINDAMYCIN PHOSPHATE GEL [PREFERRED PHARMACEUTICALS, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CLINDAMYCIN PHOSPHATE GEL [PREFERRED PHARMACEUTICALS, INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CLINDAMYCIN PHOSPHATE GEL [PREFERRED PHARMACEUTICALS, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R CLINDAMYCIN PHOSPHATE GEL [PREFERRED PHARMACEUTICALS, INC.] 2
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.