Cleocin Phosphate

Product NDC
0009-9890
11-digit product format
000099890
Labeler code
0009
Product ID
0009-9890_8f3a2b37-a791-49d4-83ea-8c03010c77a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clindamycin phosphate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Pharmacia and Upjohn Company LLC
Application
NDA050639
Marketing category
NDA
Marketing start
2014-09-26
Marketing end
0000-00-00
Substance
CLINDAMYCIN PHOSPHATE
Active strength
18 mg/mL
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0009-9890DDiscontinued by firm2026-10-12
excluded packagepackage0009-98900009-9890-02DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0009-9890-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0009-9890-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0009-9890-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0009-9890-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0009-9890-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0009-9890-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0009-9890-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0009-9890-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0009-9890-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0009-9890-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0009-9890-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0009-9890-02557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050639-001CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINERCLINDAMYCIN PHOSPHATEEQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-30
N050639-002CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINERCLINDAMYCIN PHOSPHATEEQ 12MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-30
N050639-003CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINERCLINDAMYCIN PHOSPHATEEQ 18MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-04-10

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N050639-001CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-3084e616aacf4f…
2026-09-14 22:38:342026-08N050639-002CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 12MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-3084e616aacf4f…
2026-09-14 22:38:342026-08N050639-003CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 18MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-04-1084e616aacf4f…
2026-08-18 06:07:402026-07N050639-001CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07N050639-002CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 12MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07N050639-003CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 18MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-04-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050639-001CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050639-002CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 12MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050639-003CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 18MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-04-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050639-001CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050639-002CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 12MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050639-003CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 18MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-04-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N050639-001CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050639-002CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 12MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050639-003CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 18MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-04-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050639-001CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050639-002CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 12MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050639-003CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 18MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-04-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050639-001CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050639-002CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 12MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050639-003CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 18MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-04-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050639-001CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050639-002CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 12MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050639-003CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 18MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-04-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050639-001CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050639-002CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 12MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050639-003CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 18MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-04-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050639-001CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050639-002CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 12MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050639-003CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 18MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-04-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050639-001CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050639-002CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 12MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050639-003CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 18MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-04-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050639-001CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-30d06236e962d9…
2024-10-29 15:01 UTC2024-10N050639-002CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 12MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-30d06236e962d9…
2024-10-29 15:01 UTC2024-10N050639-003CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 18MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-04-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050639-001CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050639-002CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 12MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050639-003CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 18MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-04-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050639-001CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-08-30301d65b070ca…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N050639-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050639-002AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050639-003AP174a2ff9319b5…
2020-12-22 03:56 UTC2020-12N050639-001AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N050639-002AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N050639-003AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050639-001AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N050639-002AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N050639-003AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050639-001AP13f01610625f2…
2019-12-14 00:12 UTC2019-12N050639-002AP13f01610625f2…
2019-12-14 00:12 UTC2019-12N050639-003AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N050639-001AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09N050639-002AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09N050639-003AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N050639-001AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07N050639-002AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07N050639-003AP1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-9890-01ML - Milliliter0009-9890c9a7e000-8035-4153-98e0-99e760b0993e12014-11-05
0009-9890-02ML - Milliliter0009-9890b2f75d05-4c3f-4622-a4b5-71f3a9e05aae12014-11-05

DailyMed Socrata Ingredients#