Clindesse

Product NDC
45802-042
11-digit product format
458020042
Labeler code
45802
Product ID
45802-042_ab0a6fe2-5ee0-408c-9e1d-30ce29344d16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clindamycin phosphate
Dosage form
CREAM
Route
VAGINAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
NDA050793
Marketing category
NDA
Marketing start
2015-07-03
Substance
CLINDAMYCIN PHOSPHATE
Active strength
100 mg/5g
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 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050793-001CLINDESSECLINDAMYCIN PHOSPHATEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-30

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N050793-00197890572026-12-02U-137Drug product2018-01-09

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-3087673890dc5c…
2021-03-12 10:30 UTC2021-03N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-303f01610625f2…
2019-09-15 20:21 UTC2019-09N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-30b00525d2431f…
2019-07-19 19:46 UTC2019-07N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-303f0d92c62455…
2023-05-13 08:27 UTC2023-05N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-30053a50430f4f…
2023-01-26 05:58 UTC2023-01N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050793-001CLINDESSEEQ 2% BASECREAM / VAGINALRLD, RS2004-11-30e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N050793-00197890572026-12-02U-137Drug product2018-01-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050793-00197890572026-12-02U-137Drug product2018-01-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050793-00197890572026-12-02U-137Drug product2018-01-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N050793-00197890572026-12-02U-137Drug product2018-01-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050793-00197890572026-12-02U-137Drug product2018-01-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050793-00197890572026-12-02U-137Drug product2018-01-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050793-00197890572026-12-02U-137Drug product2018-01-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050793-00197890572026-12-02U-137Drug product2018-01-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050793-00197890572026-12-02U-137Drug product2018-01-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050793-00197890572026-12-02U-137Drug product2018-01-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050793-00197890572026-12-02U-137Drug product2018-01-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050793-00197890572026-12-02U-137Drug product2018-01-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050793-00197890572026-12-02U-137Drug product2018-01-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050793-00197890572026-12-02U-137Drug product2018-01-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050793-00197890572026-12-02U-137Drug product2018-01-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050793-00168998902023-04-27U-137Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050793-00197890572026-12-02U-137Drug product2018-01-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050793-00168998902023-04-27U-137Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050793-00197890572026-12-02U-137Drug product2018-01-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050793-00168998902023-04-27U-137Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050793-00197890572026-12-02U-137Drug product2018-01-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050793-00168998902023-04-27U-137Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050793-00197890572026-12-02U-137Drug product2018-01-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050793-00168998902023-04-27U-137Drug productbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050793-00197890572026-12-02U-137Drug product2018-01-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050793-00168998902023-04-27U-137Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N050793-00197890572026-12-02U-137Drug product2018-01-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050793-00168998902023-04-27U-137Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050793-00197890572026-12-02U-137Drug product2018-01-0987673890dc5c…
2021-03-12 10:30 UTC2021-03N050793-00168998902023-04-27U-137Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N050793-00197890572026-12-02U-137Drug product2018-01-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050793-00168998902023-04-27U-137Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N050793-00197890572026-12-02U-137Drug product2018-01-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050793-00168998902023-04-27U-137Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N050793-00197890572026-12-02U-137Drug product2018-01-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050793-00168998902023-04-27U-137Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N050793-00197890572026-12-02U-137Drug product2018-01-093f01610625f2…
2019-09-15 20:21 UTC2019-09N050793-00168998902023-04-27U-137Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N050793-00197890572026-12-02U-137Drug product2018-01-09b00525d2431f…
2019-07-19 19:46 UTC2019-07N050793-00168998902023-04-27U-137Drug productea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
Clindesse
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN PHOSPHATE100 mg/5g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EH6D7113I8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309337Internal RxNorm lookup
602427Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fe8bb204-f173-44fe-803b-b08f2ec5aa31Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d8f81258-db12-0761-46cc-8ff6e62e9302Product name420240422
b7b2fa42-1c77-d724-81f0-87da60a77e79Product name320240320
b27c7c65-51f2-a62f-e0e6-a26b3a0f8eb0Product name320230425
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
ffb4bacf-f636-0f7d-0b0d-7a4b151243e3Product name920220928
b72227d6-0388-43bd-995b-b762d2754cd5Product name120220706
a92d22e0-3af4-f301-bc88-27ff030b0070Product name220220316
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
5ce6ce33-4f2b-3ce0-757d-e520013280cfProduct name520180719
b92a26f1-6926-4817-be73-e26ab4c2146fProduct name120170602
028d6c95-5012-6976-2075-dee0ae6fefe2Product name120140508
468b2c08-8adb-8d0f-8257-c6515a061424Product name120140508
8959fb29-d86f-c521-666a-b4cb22233594Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-042-01Clindesse5 g in 1 APPLICATORCREAM512
45802-042-01Clindesse1 in 1 CARTONCREAM112
45802-042-02Clindesse1 in 1 CARTONCREAM112
45802-042-02Clindesse5 g in 1 APPLICATORCREAM512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-042-01GM - Gram45802-04283e90ef2-4fea-4214-b68e-1d192d02d69412015-07-20

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-042CLINDESSE (CLINDAMYCIN PHOSPHATE) CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]11Current NDC, Legacy NDC, 4 package rows20250207_fe8bb204-f173-44fe-803b-b08f2ec5aa31.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClindesseCLINDAMYCIN PHOSPHATEPadagis Israel Pharmaceuticals Ltdfe8bb204-f173-44fe-803b-b08f2ec5aa312025-01-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 050793
application number: NDA050793
ndc (product): 45802-042

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309337clindamycin phosphate 2 % Vaginal CreamPSNfe8bb204-f173-44fe-803b-b08f2ec5aa3112
602427Clindesse 2 % Vaginal CreamPSNfe8bb204-f173-44fe-803b-b08f2ec5aa3112
602427clindamycin 20 MG/ML Vaginal Cream [Clindesse]SBDfe8bb204-f173-44fe-803b-b08f2ec5aa3112
309337clindamycin 20 MG/ML Vaginal CreamSCDfe8bb204-f173-44fe-803b-b08f2ec5aa3112
309337clindamycin (as clindamycin phosphate) 2 % Vaginal CreamSYfe8bb204-f173-44fe-803b-b08f2ec5aa3112
309337clindamycin 2 % Vaginal CreamSYfe8bb204-f173-44fe-803b-b08f2ec5aa3112
602427Clindesse (as clindamycin phosphate) 2 % Vaginal CreamSYfe8bb204-f173-44fe-803b-b08f2ec5aa3112
602427Clindesse 2 % Vaginal CreamSYfe8bb204-f173-44fe-803b-b08f2ec5aa3112
602427Clindesse 20 MG/ML Vaginal CreamSYfe8bb204-f173-44fe-803b-b08f2ec5aa3112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-042-01458020042011 APPLICATOR in 1 CARTON (45802-042-01) / 5 g in 1 APPLICATOR1 applicator2015-07-030000-00-00NoNoCurrent
45802-042-02458020042021 APPLICATOR in 1 CARTON (45802-042-02) / 5 g in 1 APPLICATOR1 applicator2015-07-030000-00-00YesNoCurrent