Clindamycin in 5 Percent Dextrose

Product NDC
0781-9222
Requested package NDC
0781-9222-09
11-digit product format
007819222
Labeler code
0781
Product ID
0781-9222_9ab06e2f-6a2f-41a5-8386-81d3aba03cfc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin in 5 Percent Dextrose
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA201692
Marketing category
ANDA
Marketing start
2014-03-01
Marketing end
0000-00-00
Substance
CLINDAMYCIN
Active strength
18 mg/mL
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0781-92220781-9222-09DDiscontinued by firm2026-08-11

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A201692-001CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINERCLINDAMYCIN PHOSPHATEEQ 6MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-31
A201692-002CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINERCLINDAMYCIN PHOSPHATEEQ 12MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-31
A201692-003CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINERCLINDAMYCIN PHOSPHATEEQ 18MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A201692-001AP
A201692-002AP
A201692-003AP

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A201692-001CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 6MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201692-002CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 12MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201692-003CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 18MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201692-001CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 6MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201692-002CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 12MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201692-003CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 18MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201692-001CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 6MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201692-002CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 12MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201692-003CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 18MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201692-001CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 6MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201692-002CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 12MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201692-003CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 18MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201692-001CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 6MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201692-002CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 12MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201692-003CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 18MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201692-001CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 6MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201692-002CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 12MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201692-003CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 18MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201692-001CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 6MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201692-002CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 12MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201692-003CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 18MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201692-001CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 6MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201692-002CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 12MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201692-003CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 18MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201692-001CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 6MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201692-002CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 12MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201692-003CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 18MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201692-001CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 6MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A201692-002CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 12MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A201692-003CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 18MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201692-001CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 6MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201692-002CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 12MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201692-003CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 18MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201692-001CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 6MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201692-002CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 12MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201692-003CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 18MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201692-001CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 6MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201692-002CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 12MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201692-003CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 18MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201692-001CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINEREQ 6MG BASE/MLINJECTABLE / INJECTIONAPRS2012-05-318072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A201692-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201692-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201692-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201692-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201692-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201692-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201692-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201692-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201692-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201692-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201692-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201692-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201692-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201692-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201692-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201692-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201692-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201692-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201692-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201692-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201692-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201692-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201692-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201692-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201692-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201692-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201692-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201692-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201692-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201692-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201692-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201692-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201692-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201692-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201692-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201692-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201692-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201692-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201692-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201692-001AP18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-9222-09ML - Milliliter0781-9222af5b727c-bf46-46cb-bd72-e8b4f4d66d1f12014-08-01
0781-9222-91ML - Milliliter0781-9222fbebcb65-b762-426a-9d13-fe8e998668d412018-03-08

DailyMed Socrata Ingredients#

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clindamycin in 5 Percent DextroseCLINDAMYCIN IN 5 PERCENT DEXTROSECivica, Inc.80217bd6-2bc4-401c-9345-22532b36a24f2026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201692
application number: ANDA201692
Clindamycin in 5 Percent DextroseCLINDAMYCIN IN 5 PERCENT DEXTROSESandoz Inc231d95a6-5e5f-4a45-a92b-d3d16ef0a7ca2026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201692
application number: ANDA201692

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-9222-090078192220924 BAG in 1 CARTON (0781-9222-09) > 50 mL in 1 BAG (0781-9222-91) 24 bag2014-03-010000-00-00NoNoCurrent