Home NDC 71428-003-60 Clindamycin Phosphate
Product NDC 71428-003
Requested package NDC 71428-003-60
11-digit product format 714280003
Labeler code 71428
Product ID 71428-003_ee9d6fd1-8e2b-9f28-e053-2a95a90a54f2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clindamycin Phosphate
Dosage form SOLUTION
Route TOPICAL
Labeler Glasshouse Pharmaceuticals Limited Canada
Application ANDA209846
Marketing category ANDA
Marketing start 2019-03-01
Marketing end 0000-00-00
Substance CLINDAMYCIN
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 2023-12-31
Current FDA listing Historical FDA.report record 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 A209846-001 CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209846-001 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 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209846-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION / TOPICAL AT 2018-02-08 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71428-003 CLINDAMYCIN PHOSPHATE SOLUTION [GLASSHOUSE PHARMACEUTICALS LIMITED CANADA] 6 Legacy NDC 20240111_ae7f006e-baba-4fb2-8329-35960eeaca89.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71428-003-60 71428000360 1 BOTTLE in 1 CARTON (71428-003-60) > 60 mL in 1 BOTTLE 1 bottle 2019-03-01 0000-00-00 No No Current