FDA.reportPublic FDA data

AQUASOL A

Product NDC
61703-418
Requested package NDC
61703-418-18
11-digit product format
617030418
Labeler code
61703
Product ID
61703-418_d04dff75-58eb-4656-9956-5e7cc64a3700
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VITAMIN A PALMITATE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Hospira, Inc.
Application
NDA006823
Marketing category
NDA
Marketing start
2014-07-18
Marketing end
2021-10-01
Substance
VITAMIN A PALMITATE
Active strength
15 mg/mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61703-41861703-418-18DDiscontinued by firm2026-08-03

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

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
N006823-001AQUASOL AVITAMIN A PALMITATEEQ 50,000 UNITS BASE/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N006823-001AQUASOL AEQ 50,000 UNITS BASE/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AQUASOL A ParenteralWATER-MISCIBLE RETINYL PALMITATERising Pharma Holdings, Inc.1abd66eb-6ac8-4a9e-a609-251e46ea1a272026-03-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 006823
application number: NDA006823

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61703-418-07ML - Milliliter61703-41815a9cf6a-62e6-4afe-b6ef-94e18106a71b12012-07-24
61703-418-18ML - Milliliter61703-418ed3e404a-3698-4bd2-b691-ef7f8c8a830412015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VITAMIN A PALMITATEACTIVE INGREDIENT1D1K0N0VVCAQUASOL A (VITAMIN A PALMITATE) INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]13
RETINOLACTIVE MOIETYG2SH0XKK91AQUASOL A (VITAMIN A PALMITATE) INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]13
CHLOROBUTANOLINACTIVE INGREDIENTHM4YQM8WRCAQUASOL A (VITAMIN A PALMITATE) INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]13
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPAQUASOL A (VITAMIN A PALMITATE) INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]13
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HAQUASOL A (VITAMIN A PALMITATE) INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IAQUASOL A (VITAMIN A PALMITATE) INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61703-418-18617030418181 VIAL, SINGLE-DOSE in 1 CARTON (61703-418-18) > 2 mL in 1 VIAL, SINGLE-DOSE2015-01-282021-10-01NoNoCurrent