Home NDC 45802-263 Clindamycin Phosphate
Product NDC 45802-263
11-digit product format 458020263
Labeler code 45802
Product ID 45802-263_5256413f-c2fa-4f07-8b0a-dc6d1de9539c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clindamycin Phosphate
Dosage form SOLUTION
Route TOPICAL
Labeler Padagis Israel Pharmaceuticals Ltd
Application ANDA065049
Marketing category ANDA
Marketing start 2006-05-31
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 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 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 A065049-001 CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065049-001 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 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT 2000-05-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT 2000-05-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT 2000-05-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT 2000-05-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT 2000-05-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT 2000-05-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT 2000-05-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065049-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB / TOPICAL AT RS 2000-05-25 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 45802-263-37 Clindamycin Phosphate 1 mL in 1 APPLICATOR SOLUTION 1 15 45802-263-37 Clindamycin Phosphate 60 in 1 JAR SOLUTION 60 15 45802-263-93 Clindamycin Phosphate 1 mL in 1 APPLICATOR SOLUTION 1 15 45802-263-93 Clindamycin Phosphate 69 in 1 JAR SOLUTION 69 15
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45802-263 CLINDAMYCIN PHOSPHATE SOLUTION [PADAGIS ISRAEL PHARMACEUTICALS LTD] 13 Current NDC, Legacy NDC, 4 package rows 20230523_e492d645-7d2e-4f8a-a43a-9999456e9f72.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 · 4 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 45802-263-37 45802026337 60 APPLICATOR in 1 JAR (45802-263-37) / 1 mL in 1 APPLICATOR 60 applicator 2006-05-31 0000-00-00 No No Current 45802-263-93 45802026393 1 mL in 1 APPLICATOR 1 ml Historical