Home NDC 72578-084 Clindamycin Phosphate
Product NDC 72578-084
11-digit product format 725780084
Labeler code 72578
Product ID 72578-084_a9c14275-709a-4b1b-aa37-2dcc57465489
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clindamycin Phosphate
Dosage form SOLUTION
Route TOPICAL
Labeler Viona Pharmaceuticals Inc
Application ANDA208767
Marketing category ANDA
Marketing start 2020-06-15
Substance CLINDAMYCIN PHOSPHATE
Active strength 10 mg/mL
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 A208767-001 CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208767-001 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 · 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 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208767-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-07-16 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Clindamycin Phosphate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLINDAMYCIN PHOSPHATE 10 mg/mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309333 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 72578-084-02 Clindamycin Phosphate 30 mL in 1 BOTTLE, WITH APPLICATOR SOLUTION 30 5 72578-084-02 Clindamycin Phosphate 1 in 1 CARTON SOLUTION 1 5 72578-084-03 Clindamycin Phosphate 60 mL in 1 BOTTLE, WITH APPLICATOR SOLUTION 60 5 72578-084-03 Clindamycin Phosphate 1 in 1 CARTON SOLUTION 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72578-084 CLINDAMYCIN PHOSPHATE SOLUTION [VIONA PHARMACEUTICALS INC] 3 Current NDC, Legacy NDC, 4 package rows 20221007_585e8b72-b350-451f-a232-199b1a01e8ce.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 · 3 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 72578-084-02 72578008402 1 BOTTLE, WITH APPLICATOR in 1 CARTON (72578-084-02) / 30 mL in 1 BOTTLE, WITH APPLICATOR 2020-06-15 0000-00-00 No No Current 72578-084-03 72578008403 1 BOTTLE, WITH APPLICATOR in 1 CARTON (72578-084-03) / 60 mL in 1 BOTTLE, WITH APPLICATOR 2020-06-15 0000-00-00 No No Current