Home NDC 0009-3448 Cleocin
Product NDC 0009-3448
11-digit product format 000093448
Labeler code 0009
Product ID 0009-3448_08bcc2dc-71ea-4664-89e8-73d6a3a01322
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clindamycin phosphate
Dosage form CREAM
Route VAGINAL
Labeler Pharmacia & Upjohn Company LLC
Application NDA050680
Marketing category NDA
Marketing start 1992-08-11
Substance CLINDAMYCIN PHOSPHATE
Active strength 20 mg/g
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 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050680-001 CLEOCIN CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL 1992-08-11 N050680-002 CLEOCIN CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB RLD, RS 1998-03-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050680-002 AB
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 3 · 84 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 2026-08-18 06:07:40 2026-07 N050680-001 CLEOCIN EQ 2% BASE CREAM / VAGINAL 1992-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N050680-002 CLEOCIN EQ 2% BASE CREAM / VAGINAL AB RLD, RS 1998-03-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050680-001 CLEOCIN EQ 2% BASE CREAM / VAGINAL 1992-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050680-002 CLEOCIN EQ 2% BASE CREAM / VAGINAL AB RLD, RS 1998-03-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050680-001 CLEOCIN EQ 2% BASE CREAM / VAGINAL 1992-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050680-002 CLEOCIN EQ 2% BASE CREAM / VAGINAL AB RLD, RS 1998-03-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050680-001 CLEOCIN EQ 2% BASE CREAM / VAGINAL 1992-08-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050680-002 CLEOCIN EQ 2% BASE CREAM / VAGINAL AB RLD, RS 1998-03-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050680-001 CLEOCIN EQ 2% BASE CREAM / VAGINAL 1992-08-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050680-002 CLEOCIN EQ 2% BASE CREAM / VAGINAL AB RLD, RS 1998-03-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050680-001 CLEOCIN EQ 2% BASE CREAM / VAGINAL 1992-08-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050680-002 CLEOCIN EQ 2% BASE CREAM / VAGINAL AB RLD, RS 1998-03-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050680-001 CLEOCIN EQ 2% BASE CREAM / VAGINAL 1992-08-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050680-002 CLEOCIN EQ 2% BASE CREAM / VAGINAL AB RLD, RS 1998-03-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050680-001 CLEOCIN EQ 2% BASE CREAM / VAGINAL 1992-08-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050680-002 CLEOCIN EQ 2% BASE CREAM / VAGINAL AB RLD, RS 1998-03-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050680-001 CLEOCIN EQ 2% BASE CREAM / VAGINAL 1992-08-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050680-002 CLEOCIN EQ 2% BASE CREAM / VAGINAL AB RLD, RS 1998-03-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050680-001 CLEOCIN EQ 2% BASE CREAM / VAGINAL 1992-08-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050680-002 CLEOCIN EQ 2% BASE CREAM / VAGINAL AB RLD, RS 1998-03-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050680-001 CLEOCIN EQ 2% BASE CREAM / VAGINAL 1992-08-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050680-002 CLEOCIN EQ 2% BASE CREAM / VAGINAL AB RLD, RS 1998-03-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050680-001 CLEOCIN EQ 2% BASE CREAM / VAGINAL 1992-08-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050680-002 CLEOCIN EQ 2% BASE CREAM / VAGINAL AB RLD, RS 1998-03-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050680-001 CLEOCIN EQ 2% BASE CREAM / VAGINAL 1992-08-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050680-002 CLEOCIN EQ 2% BASE CREAM / VAGINAL AB RLD, RS 1998-03-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050680-001 CLEOCIN EQ 2% BASE CREAM / VAGINAL 1992-08-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050680-002 CLEOCIN EQ 2% BASE CREAM / VAGINAL AB RLD, RS 1998-03-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050680-001 CLEOCIN EQ 2% BASE CREAM / VAGINAL 1992-08-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050680-002 CLEOCIN EQ 2% BASE CREAM / VAGINAL AB RLD, RS 1998-03-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050680-001 CLEOCIN EQ 2% BASE CREAM / VAGINAL 1992-08-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050680-002 CLEOCIN EQ 2% BASE CREAM / VAGINAL AB RLD, RS 1998-03-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050680-001 CLEOCIN EQ 2% BASE CREAM / VAGINAL 1992-08-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050680-002 CLEOCIN EQ 2% BASE CREAM / VAGINAL AB RLD, RS 1998-03-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050680-001 CLEOCIN EQ 2% BASE CREAM / VAGINAL 1992-08-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050680-002 CLEOCIN EQ 2% BASE CREAM / VAGINAL AB RLD, RS 1998-03-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050680-001 CLEOCIN EQ 2% BASE CREAM / VAGINAL 1992-08-11 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050680-002 CLEOCIN EQ 2% BASE CREAM / VAGINAL AB RLD, RS 1998-03-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050680-001 CLEOCIN EQ 2% BASE CREAM / VAGINAL 1992-08-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050680-002 CLEOCIN EQ 2% BASE CREAM / VAGINAL AB RLD, RS 1998-03-02 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Cleocin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLINDAMYCIN PHOSPHATE 20 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination EH6D7113I8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309337 Internal RxNorm lookup 882536 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 0009-3448-01 Cleocin 40 g in 1 TUBE, WITH APPLICATOR CREAM 40 23 0009-3448-01 Cleocin 1 in 1 CARTON CREAM 1 23
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0009-3448 CLEOCIN (CLINDAMYCIN PHOSPHATE) CREAM [PHARMACIA & UPJOHN COMPANY LLC] 22 Current NDC, Legacy NDC, 2 package rows 20250406_f9be442d-0782-4b93-828f-9ebbf67dbced.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 Marketing start Marketing end Sample Exclude flag Status 0009-3448-01 00009344801 1 TUBE, WITH APPLICATOR in 1 CARTON (0009-3448-01) / 40 g in 1 TUBE, WITH APPLICATOR 1992-08-11 0000-00-00 No No Current