Home NDC 21922-002 Clindamycin Phoaphate Topical Solution USP, 1%
Product NDC 21922-002
11-digit product format 219220002
Labeler code 21922
Product ID 21922-002_0babc3d6-8dfa-4034-8811-24af75b21048
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clindamycin Phosphate Topical Solution USP, 1%
Dosage form SOLUTION
Route TOPICAL
Labeler Encube Ethicals, Inc.
Application ANDA209914
Marketing category ANDA
Marketing start 2019-03-04
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 2026-12-31
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 A209914-001 CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209914-001 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 · 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 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209914-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2019-01-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Clindamycin Phoaphate Topical Solution USP, 1%
Listing expiration 2026-12-31 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 21922-002-01 Clindamycin Phoaphate Topical Solution USP, 1% 60 mL in 1 BOTTLE SOLUTION 60 8 21922-002-01 Clindamycin Phoaphate Topical Solution USP, 1% 1 in 1 CARTON SOLUTION 1 8 21922-002-21 Clindamycin Phoaphate Topical Solution USP, 1% 1 in 1 CARTON SOLUTION 1 8 21922-002-21 Clindamycin Phoaphate Topical Solution USP, 1% 30 mL in 1 BOTTLE SOLUTION 30 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21922-002 CLINDAMYCIN PHOAPHATE TOPICAL SOLUTION USP, 1% (CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION USP, 1%) SOLUTION [ENCUBE ETHICALS PRIVATE LIMITED] 7 Current NDC, Legacy NDC, 4 package rows 20241212_b2dfb76b-db09-43e7-8366-6791449a4918.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Clindamycin Phoaphate Topical Solution USP, 1% CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION USP, 1% Encube Ethicals, Inc. b2dfb76b-db09-43e7-8366-6791449a4918 2025-09-05 Warnings, Adverse reactions Exact identifier application applno (ANDA): 209914 application number: ANDA209914 ndc (product): 21922-002 Clindamycin Phoaphate Topical Solution USP, 1% CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION USP, 1% Northstar Rx LLC 407f6d80-7de0-45d9-8ad2-5b95d233b96d 2024-11-08 Warnings, Adverse reactions Exact identifier application applno (ANDA): 209914 application number: ANDA209914 Clindamycin Phoaphate Topical USP, 1% CLINDAMYCIN PHOSPHATE TOPICAL USP, 1% A-S Medication Solutions 19363055-9ae7-4f0f-979d-93d0ee2c803f 2024-05-06 Warnings, Adverse reactions Exact identifier application applno (ANDA): 209914 application number: ANDA209914
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 21922-002-01 21922000201 1 BOTTLE in 1 CARTON (21922-002-01) / 60 mL in 1 BOTTLE 1 bottle 2019-03-04 0000-00-00 No No Current 21922-002-21 21922000221 1 BOTTLE in 1 CARTON (21922-002-21) / 30 mL in 1 BOTTLE 1 bottle 2020-07-13 0000-00-00 No No Current