Home NDC 65162-468-19 Clindamycin Palmitate Hydrochloride
Product NDC 65162-468
Requested package NDC 65162-468-19
11-digit product format 651620468
Labeler code 65162
Product ID 65162-468_4480ac35-28fd-48fc-b0eb-52349d30ad8e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clindamycin Palmitate Hydrochloride
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA203513
Marketing category ANDA
Marketing start 2013-09-02
Substance CLINDAMYCIN PALMITATE HYDROCHLORIDE
Active strength 75 mg/5mL
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 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL 2014-03-13
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 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203513-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2014-03-13 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Clindamycin Palmitate Hydrochloride
Brand name suffix (Pediatric)
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLINDAMYCIN PALMITATE HYDROCHLORIDE 75 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VN9A8JM7M7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 562266 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65162-468-19 Clindamycin Palmitate Hydrochloride(Pediatric) 100 mL in 1 BOTTLE POWDER, FOR SOLUTION 100 17 65162-468-19 Clindamycin Palmitate Hydrochloride(Pediatric) 1 in 1 CARTON POWDER, FOR SOLUTION 1 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLINDAMYCIN PALMITATE HYDROCHLORIDE ACTIVE INGREDIENT VN9A8JM7M7 CLINDAMYCIN PALMITATE HYDROCHLORIDE POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 5 CLINDAMYCIN ACTIVE MOIETY 3U02EL437C CLINDAMYCIN PALMITATE HYDROCHLORIDE POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 5 CHERRY INACTIVE INGREDIENT BUC5I9595W CLINDAMYCIN PALMITATE HYDROCHLORIDE POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 5 ETHYLPARABEN INACTIVE INGREDIENT 14255EXE39 CLINDAMYCIN PALMITATE HYDROCHLORIDE POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 5 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D CLINDAMYCIN PALMITATE HYDROCHLORIDE POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 5 POLOXAMER 188 INACTIVE INGREDIENT LQA7B6G8JG CLINDAMYCIN PALMITATE HYDROCHLORIDE POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 5 SUCROSE INACTIVE INGREDIENT C151H8M554 CLINDAMYCIN PALMITATE HYDROCHLORIDE POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-468 CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC) (CLINDAMYCIN PALMITATE HYDROCHLORIDE) POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS LLC] 17 Current NDC, Legacy NDC, 2 package rows 20241027_a85e28ea-03be-471f-ad7f-f5c55c67ac97.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.
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 65162-468-19 65162046819 1 BOTTLE in 1 CARTON (65162-468-19) / 100 mL in 1 BOTTLE 1 bottle 2013-09-02 0000-00-00 No No Current