Home NDC 53746-468 Clindamycin Palmitate Hydrochloride
Product NDC 53746-468
11-digit product format 537460468
Labeler code 53746
Product ID 53746-468_b9016023-7843-48e3-8ff6-2e5a70aa5daf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clindamycin Palmitate Hydrochloride
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA203513
Marketing category ANDA
Marketing start 2024-04-01
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53746-468-19 Clindamycin Palmitate Hydrochloride(Pediatric) 1 in 1 CARTON POWDER, FOR SOLUTION 1 2 53746-468-19 Clindamycin Palmitate Hydrochloride(Pediatric) 100 mL in 1 BOTTLE POWDER, FOR SOLUTION 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53746-468 CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC) (CLINDAMYCIN PALMITATE HYDROCHLORIDE) POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 2 Current NDC, 2 package rows 20240427_faf67eb8-1fd7-4b2c-a55b-24ba664c0dce.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 Sample Exclude flag Status 53746-468-19 53746046819 1 BOTTLE in 1 CARTON (53746-468-19) / 100 mL in 1 BOTTLE 1 bottle 2024-04-01 No No Current