Home NDC 10135-691-61 Clindamycin Phosphate
Product NDC 10135-691
Requested package NDC 10135-691-61
11-digit product format 101350691
Labeler code 10135
Product ID 10135-691_ec98a8b7-7c90-6912-e053-2a95a90a2791
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clindamycin Phosphate
Dosage form SOLUTION
Route TOPICAL
Labeler Marlex Pharmaceuticals Inc
Application ANDA209846
Marketing category ANDA
Marketing start 2020-03-01
Marketing end 0000-00-00
Substance CLINDAMYCIN PHOSPHATE
Active strength 12 mg/mL
Pharmacologic classes Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A209846-001 CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209846-001 AT
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 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 10135-691-61 Clindamycin Phosphate 1 in 1 CARTON SOLUTION 1 4 10135-691-61 Clindamycin Phosphate 60 mL in 1 BOTTLE, WITH APPLICATOR SOLUTION 60 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10135-691 CLINDAMYCIN PHOSPHATE SOLUTION [MARLEX PHARMACEUTICALS INC] 4 Legacy NDC, 2 package rows 20221104_ab4e9054-348c-4e7b-ae04-1163ac9a15f9.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 Marketing start Marketing end Sample Exclude flag Status 10135-691-61 10135069161 1 BOTTLE, WITH APPLICATOR in 1 CARTON (10135-691-61) > 60 mL in 1 BOTTLE, WITH APPLICATOR 2020-03-01 0000-00-00 No No Current