Home NDC 78206-189 XACIATO
Product NDC 78206-189
11-digit product format 782060189
Labeler code 78206
Product ID 78206-189_1319a6c2-eed2-49b6-9ec8-85d44fae9b91
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clindamycin phosphate
Dosage form GEL
Route VAGINAL
Labeler Organon LLC
Application NDA215650
Marketing category NDA
Marketing start 2023-10-13
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 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base XACIATO
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 2587810 Internal RxNorm lookup 2587815 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 78206-189-01 XACIATO 8 g in 1 TUBE GEL 8 13 78206-189-01 XACIATO 1 in 1 CARTON GEL 1 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78206-189 XACIATO (CLINDAMYCIN PHOSPHATE) GEL [ORGANON LLC] 11 Current NDC, 2 package rows 20240217_0423007f-28fa-4159-bf58-9174626d2347.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 78206-189-01 78206018901 1 TUBE in 1 CARTON (78206-189-01) / 8 g in 1 TUBE 1 tube 2023-10-13 No No Current