Home NDC 21922-036 Clindamycin Phosphate
Product NDC 21922-036
11-digit product format 219220036
Labeler code 21922
Product ID 21922-036_4eb63972-d25b-45d6-81dd-7988d0467c20
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clindamycin Phosphate
Dosage form LOTION
Route TOPICAL
Labeler Encube Ethicals, Inc.
Application ANDA215607
Marketing category ANDA
Marketing start 2022-01-19
Substance CLINDAMYCIN PHOSPHATE
Active strength 10 ug/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 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 A215607-001 CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215607-001 AB
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 2026-02-19 14:30 UTC 2026-02 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215607-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE LOTION / TOPICAL AB 2022-01-18 a50c72e98297…
Observed Orange Book normalized TE history# 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 ug/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 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 21922-036-01 Clindamycin Phosphate 1 in 1 CARTON LOTION 1 3 21922-036-01 Clindamycin Phosphate 60 mL in 1 BOTTLE LOTION 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21922-036 CLINDAMYCIN PHOSPHATE LOTION [ENCUBE ETHICALS PRIVATE LIMITED] 1 Current NDC, Legacy NDC, 2 package rows 20220121_ba6ae5da-affa-422b-9a53-28f3fc001523.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 21922-036-01 21922003601 1 BOTTLE in 1 CARTON (21922-036-01) / 60 mL in 1 BOTTLE 1 bottle 2022-01-19 0000-00-00 No No Current