Home NDC 81505-100 XACIATO
Product NDC 81505-100
11-digit product format 815050100
Labeler code 81505
Product ID 81505-100_b7389fbe-b3f3-44e0-bf24-9ce118a41501
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clindamycin phosphate
Dosage form GEL
Route VAGINAL
Labeler Dar
Application NDA215650
Marketing category NDA
Marketing start 2021-12-21
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],Neuromuscular Blockade [PE]
NDC exclude flag No
Listing certified through 2022-12-31
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 81505-100-25 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 81505-100-25 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 81505-100-25 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 81505-100-25 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 81505-100-25 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 81505-100-25 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 81505-100-25 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 81505-100-25 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 81505-100-25 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 81505-100-25 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 81505-100-25 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 81505-100-25 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N215650-001 XACIATO CLINDAMYCIN PHOSPHATE EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215650-001 11129896 2036-09-22 U-3293 2022-02-03 N215650-001 12303563 2036-09-22 Drug product 2025-06-16
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215650-001 NP 2024-12-07 N215650-001 GAIN 2029-12-07
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.
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 2026-09-14 22:38:34 2026-08 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215650-001 12303563 2036-09-22 Drug product 2025-06-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215650-001 12303563 2036-09-22 Drug product 2025-06-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215650-001 12303563 2036-09-22 Drug product 2025-06-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215650-001 12303563 2036-09-22 Drug product 2025-06-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215650-001 12303563 2036-09-22 Drug product 2025-06-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215650-001 12303563 2036-09-22 Drug product 2025-06-16 a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 68 observed states.
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 XACIATO CLINDAMYCIN PHOSPHATE Organon LLC 0423007f-28fa-4159-bf58-9174626d2347 2026-02-19 Warnings, Adverse reactions Exact identifier application applno (NDA): 215650 application number: NDA215650
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 81505-100-25 81505010025 25 g in 1 TUBE (81505-100-25) 25 g 2021-12-21 0000-00-00 No No Current