Home NDC 45802-042 Clindesse
Product NDC 45802-042
11-digit product format 458020042
Labeler code 45802
Product ID 45802-042_ab0a6fe2-5ee0-408c-9e1d-30ce29344d16
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clindamycin phosphate
Dosage form CREAM
Route VAGINAL
Labeler Padagis Israel Pharmaceuticals Ltd
Application NDA050793
Marketing category NDA
Marketing start 2015-07-03
Substance CLINDAMYCIN PHOSPHATE
Active strength 100 mg/5g
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 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 N050793-001 CLINDESSE CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09
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 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050793-001 CLINDESSE EQ 2% BASE CREAM / VAGINAL RLD, RS 2004-11-30 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 2 · 66 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050793-001 6899890 2023-04-27 U-137 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050793-001 6899890 2023-04-27 U-137 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050793-001 6899890 2023-04-27 U-137 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050793-001 6899890 2023-04-27 U-137 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050793-001 6899890 2023-04-27 U-137 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050793-001 6899890 2023-04-27 U-137 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050793-001 6899890 2023-04-27 U-137 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050793-001 6899890 2023-04-27 U-137 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050793-001 6899890 2023-04-27 U-137 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050793-001 6899890 2023-04-27 U-137 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050793-001 6899890 2023-04-27 U-137 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050793-001 6899890 2023-04-27 U-137 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N050793-001 9789057 2026-12-02 U-137 Drug product 2018-01-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050793-001 6899890 2023-04-27 U-137 Drug product ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base Clindesse
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLINDAMYCIN PHOSPHATE 100 mg/5g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination EH6D7113I8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309337 Internal RxNorm lookup 602427 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45802-042 CLINDESSE (CLINDAMYCIN PHOSPHATE) CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD] 11 Current NDC, Legacy NDC, 4 package rows 20250207_fe8bb204-f173-44fe-803b-b08f2ec5aa31.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Clindesse CLINDAMYCIN PHOSPHATE Padagis Israel Pharmaceuticals Ltd fe8bb204-f173-44fe-803b-b08f2ec5aa31 2025-01-30 Warnings, Adverse reactions Exact identifier application applno (NDA): 050793 application number: NDA050793 ndc (product): 45802-042
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 45802-042-01 45802004201 1 APPLICATOR in 1 CARTON (45802-042-01) / 5 g in 1 APPLICATOR 1 applicator 2015-07-03 0000-00-00 No No Current 45802-042-02 45802004202 1 APPLICATOR in 1 CARTON (45802-042-02) / 5 g in 1 APPLICATOR 1 applicator 2015-07-03 0000-00-00 Yes No Current