Home NDC 63629-2391 CLINDAMYCIN PALMITATE HYDROCHLORIDE
Product NDC 63629-2391
11-digit product format 636292391
Labeler code 63629
Product ID 63629-2391_9fa1fe7d-c938-41cc-a2a7-5be0fa4dbc35
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CLINDAMYCIN PALMITATE HYDROCHLORIDE
Dosage form GRANULE, FOR SOLUTION
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA201821
Marketing category ANDA
Marketing start 2012-09-11
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 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201821-001 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 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201821-001 CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION / ORAL AA 2012-08-28 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
Brand name suffix (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 63629-2391-1 CLINDAMYCIN PALMITATE HYDROCHLORIDE(Pediatric) 100 mL in 1 BOTTLE GRANULE, FOR SOLUTION 100 107
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-2391 CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC) (CLINDAMYCIN PALMITATE HYDROCHLORIDE) GRANULE, FOR SOLUTION [BRYANT RANCH PREPACK] 107 Current NDC, Legacy NDC, 1 package rows 20240905_3afe52c2-b65b-40fe-b2fa-da39f1bcf529.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 · 3 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 63629-2391-1 63629239101 100 mL in 1 BOTTLE (63629-2391-1) 100 ml 2021-02-23 0000-00-00 No No Current