Home NDC 59762-0016 clindamycin palmitate hydrochloride
Product NDC 59762-0016
11-digit product format 597620016
Labeler code 59762
Product ID 59762-0016_0b11c51d-9e09-4ab9-a0b6-e394b4167de9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clindamycin palmitate hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Greenstone LLC
Application ANDA062644
Marketing category ANDA
Marketing start 1986-04-07
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 59762-0016-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 59762-0016-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 59762-0016-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 59762-0016-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 59762-0016-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 59762-0016-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 59762-0016-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 59762-0016-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 59762-0016-1 0efc9e666f02…f202fb6c5f17…
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 A062644-001 CLEOCIN CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A062644-001 AA
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 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A062644-001 CLEOCIN EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA RS 1986-04-07 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Socrata Ingredients# 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cleocin Pediatric CLINDAMYCIN PALMITATE HYDROCHLORIDE Pharmacia & Upjohn Company LLC 1ef87b6c-9d32-44ac-8c55-8bf01424cc45 2026-06-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 062644 application number: ANDA062644
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59762-0016-1 59762001601 1 BOTTLE in 1 CARTON (59762-0016-1) > 100 mL in 1 BOTTLE 1 bottle 1986-04-07 0000-00-00 No No Current