Home NDC 0009-0760 Cleocin Pediatric
Product NDC 0009-0760
11-digit product format 000090760
Labeler code 0009
Product ID 0009-0760_b53fb12e-75af-47c6-8777-0e8f1e36c47f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clindamycin palmitate hydrochloride
Dosage form GRANULE, FOR SOLUTION
Route ORAL
Labeler Pharmacia & Upjohn Company LLC
Application ANDA062644
Marketing category ANDA
Marketing start 1986-04-17
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 2027-12-31
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 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.
Additional Listing Data#
Finished product Yes
Brand name base Cleocin 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 562266 Internal RxNorm lookup 748743 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 0009-0760-04 Cleocin Pediatric 1 in 1 CARTON GRANULE, FOR SOLUTION 1 34 0009-0760-04 Cleocin Pediatric 100 mL in 1 BOTTLE GRANULE, FOR SOLUTION 100 34 0009-0760-12 Cleocin Pediatric 100 mL in 1 BOTTLE GRANULE, FOR SOLUTION 100 34 0009-0760-12 Cleocin Pediatric 1 in 1 CARTON GRANULE, FOR SOLUTION 1 34
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLINDAMYCIN PALMITATE HYDROCHLORIDE ACTIVE INGREDIENT VN9A8JM7M7 CLEOCIN PEDIATRIC (CLINDAMYCIN PALMITATE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMACIA AND UPJOHN COMPANY] 9 CLINDAMYCIN ACTIVE MOIETY 3U02EL437C CLEOCIN PEDIATRIC (CLINDAMYCIN PALMITATE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMACIA AND UPJOHN COMPANY] 9 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O CLEOCIN PEDIATRIC (CLINDAMYCIN PALMITATE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMACIA AND UPJOHN COMPANY] 9 ETHYLPARABEN INACTIVE INGREDIENT 14255EXE39 CLEOCIN PEDIATRIC (CLINDAMYCIN PALMITATE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMACIA AND UPJOHN COMPANY] 9 ICODEXTRIN INACTIVE INGREDIENT 2NX48Z0A9G CLEOCIN PEDIATRIC (CLINDAMYCIN PALMITATE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMACIA AND UPJOHN COMPANY] 9 POLOXAMER 188 INACTIVE INGREDIENT LQA7B6G8JG CLEOCIN PEDIATRIC (CLINDAMYCIN PALMITATE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMACIA AND UPJOHN COMPANY] 9 SUCROSE INACTIVE INGREDIENT C151H8M554 CLEOCIN PEDIATRIC (CLINDAMYCIN PALMITATE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMACIA AND UPJOHN COMPANY] 9 CLINDAMYCIN PALMITATE HYDROCHLORIDE ACTIVE INGREDIENT VN9A8JM7M7 CLEOCIN (CLINDAMYCIN PALMITATE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 CLINDAMYCIN ACTIVE MOIETY 3U02EL437C CLEOCIN (CLINDAMYCIN PALMITATE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 ETHYLPARABEN INACTIVE INGREDIENT 14255EXE39 CLEOCIN (CLINDAMYCIN PALMITATE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 CLEOCIN (CLINDAMYCIN PALMITATE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0009-0760 CLEOCIN PEDIATRIC (CLINDAMYCIN PALMITATE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMACIA & UPJOHN COMPANY LLC] 29 Current NDC, Legacy NDC, 4 package rows 20231117_1ef87b6c-9d32-44ac-8c55-8bf01424cc45.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 · 1 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 0009-0760-04 00009076004 1 BOTTLE in 1 CARTON (0009-0760-04) > 100 mL in 1 BOTTLE 1 bottle 1986-04-17 0000-00-00 No No Current 0009-0760-12 00009076012 1 BOTTLE in 1 CARTON (0009-0760-12) / 100 mL in 1 BOTTLE 1 bottle 2025-11-11 No No Current