FDA.reportPublic FDA data

Zinc Chloride

Product NDC
70069-526
11-digit product format
700690526
Labeler code
70069
Product ID
70069-526_6b701c2f-faba-4d1a-ad8d-bebaf0ec7cfa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zinc Chloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Somerset Therapeutics, LLC
Application
ANDA216152
Marketing category
ANDA
Marketing start
2024-10-16
Substance
ZINC CHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC CHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii86Q357L16B
Rxcui237508

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70069-526-01Zinc Chloride10 mL in 1 VIAL, PLASTICINJECTION104
70069-526-25Zinc Chloride25 in 1 CARTONINJECTION254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-526ZINC CHLORIDE INJECTION [SOMERSET THERAPEUTICS, LLC]4Current NDC, 2 package rows20241019_9a4f7a7b-26d0-4292-bc7b-6ca9fa48600f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
237508zinc 10 MG in 10 ML InjectionPSN9a4f7a7b-26d0-4292-bc7b-6ca9fa48600f4
23750810 ML zinc chloride 1 MG/ML InjectionSCD9a4f7a7b-26d0-4292-bc7b-6ca9fa48600f4
237508zinc (as zinc chloride) 10 MG per 10 ML InjectionSY9a4f7a7b-26d0-4292-bc7b-6ca9fa48600f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70069-526-017006905260110 mL in 1 VIAL, PLASTIC10 mlHistorical
70069-526-257006905262525 VIAL, PLASTIC in 1 CARTON (70069-526-25) / 10 mL in 1 VIAL, PLASTIC (70069-526-01) 2024-10-16NoNoCurrent