Home NDC 16714-483 Clindamycin Palmitate Hydrochloride (Pediatric)
Product NDC 16714-483
11-digit product format 167140483
Labeler code 16714
Product ID 16714-483_366c8a71-1c5c-47e8-989d-d04503c65f4b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clindamycin Palmitate Hydrochloride (Pediatric)
Dosage form SOLUTION
Route ORAL
Labeler NorthStar Rx LLC
Application ANDA202409
Marketing category ANDA
Marketing start 2013-04-30
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 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202409-001 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 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202409-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2013-04-30 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 Palmitate Hydrochloride (Pediatric)
Listing expiration 2026-12-31 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 16714-483-01 Clindamycin Palmitate Hydrochloride (Pediatric) 100 mL in 1 BOTTLE SOLUTION 100 12 16714-483-01 Clindamycin Palmitate Hydrochloride (Pediatric) 1 in 1 CARTON SOLUTION 1 12 16714-483-02 Clindamycin Palmitate Hydrochloride (Pediatric) 1 in 1 CARTON SOLUTION 1 12 16714-483-02 Clindamycin Palmitate Hydrochloride (Pediatric) 100 mL in 1 BOTTLE, PLASTIC SOLUTION 100 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-483 CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC) SOLUTION [NORTHSTAR RX LLC] 12 Current NDC, Legacy NDC, 4 package rows 20240723_b35e3714-44d1-4e6a-a124-555ad259fec1.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 16714-483-01 16714048301 1 BOTTLE in 1 CARTON (16714-483-01) / 100 mL in 1 BOTTLE 1 bottle 2013-04-30 2026-12-31 No No Current 16714-483-02 16714048302 1 BOTTLE, PLASTIC in 1 CARTON (16714-483-02) / 100 mL in 1 BOTTLE, PLASTIC 2022-11-14 No No Current