FDA.reportPublic FDA data

oxaliplatin

Product NDC
16729-332
11-digit product format
167290332
Labeler code
16729
Product ID
16729-332_0e2ec613-5375-858e-e063-6294a90ab95a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxaliplatin
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Accord Healthcare Inc.
Application
ANDA207474
Marketing category
ANDA
Marketing start
2018-05-17
Substance
OXALIPLATIN
Active strength
5 mg/mL
Pharmacologic classes
Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
oxaliplatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXALIPLATIN5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04ZR38536J
Rxcui1736776, 1736781, 1797528

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0364c41f-a4ea-b691-2739-986f76e794e5Product name920190125
b153e9b5-916b-4df6-8413-d22b82f1d312Product name220170720

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-332-03oxaliplatin1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE17
16729-332-03oxaliplatin10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE107
16729-332-05oxaliplatin1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE17
16729-332-05oxaliplatin20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE207
16729-332-35oxaliplatin40 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE407
16729-332-35oxaliplatin1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-332-03ML - Milliliter16729-3324b6ae974-1af7-42e6-9628-cdb913cab0fe12018-06-11
16729-332-05ML - Milliliter16729-332705e1342-7ba1-4f4d-b44a-427784ae64a312018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-332OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [ACCORD HEALTHCARE INC.]7Current NDC, Legacy NDC, 6 package rows20240106_4b805925-beb1-2bac-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736781oxaliplatin 100 MG in 20 ML InjectionPSN4b805925-beb1-2bac-e054-00144ff88e887
1797528oxaliplatin 200 MG in 40 ML InjectionPSN4b805925-beb1-2bac-e054-00144ff88e887
1736776oxaliplatin 50 MG in 10 ML InjectionPSN4b805925-beb1-2bac-e054-00144ff88e887
173677610 ML oxaliplatin 5 MG/ML InjectionSCD4b805925-beb1-2bac-e054-00144ff88e887
173678120 ML oxaliplatin 5 MG/ML InjectionSCD4b805925-beb1-2bac-e054-00144ff88e887
179752840 ML oxaliplatin 5 MG/ML InjectionSCD4b805925-beb1-2bac-e054-00144ff88e887
1736781oxaliplatin 100 MG per 20 ML InjectionSY4b805925-beb1-2bac-e054-00144ff88e887
1797528oxaliplatin 200 MG per 40 ML InjectionSY4b805925-beb1-2bac-e054-00144ff88e887
1736776oxaliplatin 50 MG per 10 ML InjectionSY4b805925-beb1-2bac-e054-00144ff88e887

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-332-03167290332031 VIAL, SINGLE-DOSE in 1 CARTON (16729-332-03) / 10 mL in 1 VIAL, SINGLE-DOSE2018-05-170000-00-00NoNoCurrent
16729-332-05167290332051 VIAL, SINGLE-DOSE in 1 CARTON (16729-332-05) / 20 mL in 1 VIAL, SINGLE-DOSE2018-05-170000-00-00NoNoCurrent
16729-332-351672903323540 mL in 1 VIAL, SINGLE-DOSE40 mlHistorical