Home NDC 99207-300 ZIANA
Product NDC 99207-300
11-digit product format 992070300
Labeler code 99207
Product ID 99207-300_d765377b-8dc9-4a8e-b063-9903eb4f2176
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clindamycin phosphate and tretinoin
Dosage form GEL
Route TOPICAL
Labeler Bausch Health US, LLC
Application NDA050802
Marketing category NDA
Marketing start 2006-12-01
Substance CLINDAMYCIN PHOSPHATE; TRETINOIN
Active strength 12; .25 mg/g; mg/g
Pharmacologic classes Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 12 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…
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 N050802-001 ZIANA CLINDAMYCIN PHOSPHATE; TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050802-001 AB1
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 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB RLD, RS 2006-11-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB RLD, RS 2006-11-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB RLD, RS 2006-11-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB RLD, RS 2006-11-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB RLD, RS 2006-11-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB RLD, RS 2006-11-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB RLD, RS 2006-11-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB RLD, RS 2006-11-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB RLD, RS 2006-11-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB RLD, RS 2006-11-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050802-001 ZIANA 1.2%;0.025% GEL / TOPICAL AB1 RLD, RS 2006-11-07 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 2019-12-13 00:20 UTC 2019-12 N050802-001 6387383 2020-08-03 U-916 Drug product 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N050802-001 6387383 2020-08-03 U-916 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050802-001 6387383 2020-08-03 U-916 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050802-001 6387383 2020-08-03 U-916 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050802-001 6387383 2020-08-03 U-916 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050802-001 6387383 2020-08-03 U-916 Drug product ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base ZIANA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLINDAMYCIN PHOSPHATE 12 mg/g TRETINOIN .25 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination EH6D7113I8 Internal UNII lookup 5688UTC01R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 882548 Internal RxNorm lookup 882550 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 99207-300 ZIANA (CLINDAMYCIN PHOSPHATE AND TRETINOIN) GEL [BAUSCH HEALTH US, LLC] 8 Current NDC, Legacy NDC, 6 package rows 20191211_78c329f9-f0c9-486d-9e54-0123699fb9e1.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 Units Marketing start Marketing end Sample Exclude flag Status 99207-300-02 99207030002 12 in 1 CARTON Historical 99207-300-30 99207030030 1 TUBE in 1 CARTON (99207-300-30) / 30 g in 1 TUBE 1 tube 2006-12-01 0000-00-00 No No Current 99207-300-60 99207030060 1 TUBE in 1 CARTON (99207-300-60) / 60 g in 1 TUBE 1 tube 2006-12-01 0000-00-00 No No Current