Home NDC 68788-9841 Clindamycin Phosphate
Product NDC 68788-9841
11-digit product format 687889841
Labeler code 68788
Product ID 68788-9841_24361625-0486-441b-8cad-e8f09f21f33d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clindamycin phosphate
Dosage form CREAM
Route VAGINAL
Labeler Preferred Pharmaceuticals, Inc.
Application ANDA065139
Marketing category ANDA
Marketing start 2012-03-29
Marketing end 0000-00-00
Substance CLINDAMYCIN PHOSPHATE
Active strength 20 mg/g
Pharmacologic classes Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]
NDC exclude flag No
Listing certified through 2019-12-31
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 · 26 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68788-9841-0 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68788-9841-0 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68788-9841-0 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68788-9841-0 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68788-9841-0 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68788-9841-0 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68788-9841-0 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68788-9841-0 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68788-9841-0 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68788-9841-0 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68788-9841-0 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68788-9841-0 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 68788-9841-0 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
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 A065139-001 CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065139-001 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 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLINDAMYCIN PHOSPHATE ACTIVE INGREDIENT EH6D7113I8 CLINDAMYCIN PHOSPHATE CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 CLINDAMYCIN ACTIVE MOIETY 3U02EL437C CLINDAMYCIN PHOSPHATE CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH CLINDAMYCIN PHOSPHATE CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S CLINDAMYCIN PHOSPHATE CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 CETYL PALMITATE INACTIVE INGREDIENT 5ZA2S6B08X CLINDAMYCIN PHOSPHATE CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP CLINDAMYCIN PHOSPHATE CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M CLINDAMYCIN PHOSPHATE CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CLINDAMYCIN PHOSPHATE CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 SORBITAN MONOSTEARATE INACTIVE INGREDIENT NVZ4I0H58X CLINDAMYCIN PHOSPHATE CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP CLINDAMYCIN PHOSPHATE CREAM [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.