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AQUASOL A Parenteral Water-Miscible Retinyl Palmitate 15 mg/mL Injection, Solution — NDC 64980-0721-02 package photo

AQUASOL A Parenteral Water-Miscible Retinyl Palmitate 15 mg/mL Injection, Solution

by Rising Pharma Holdings, Inc. · 1 VIAL, SINGLE-DOSE in 1 CARTON (64980-721-02) / 2 mL in 1 VIAL, SINGLE-DOSE
NDC 64980-0721-02
🏷️ FDA NDC (as labeled) 64980-721-02 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 64980-721-02
Product NDC 64980-721
11-digit billing NDC 64980072102
NCPDP billing unit ML — per mL (volume)
RxCUI 210972, 313650
UNII 1D1K0N0VVC
Application # NDA006823
SPL Set ID 1abd66eb-6ac8-4a9e-a609-251e46ea1a27
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-02-27
Route INTRAMUSCULAR
Dosage form INJECTION, SOLUTION
Substance VITAMIN A PALMITATE
GPI-14 77201010002050
GCN Seq No 058846
GCN 24367
HICL code 004766
Ingredient (HICL) Vitamin A Palmitate
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C6
Therapeutic class — intermediate (HIC2) Vitamins
HIC3 code C6A
Therapeutic class — specific (HIC3) Vitamin A Preparations
AHFS code 88:04.00.00
AHFS class Vitamin A
FDB label name AQUASOL A 100,000 UNIT/2 ML VL
FDB brand name Aquasol A
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 64980-721-02 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 64980-0721-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Vitamin A class.

Pharmacologic class Vitamin A
Drug family (ATC) Vitamin A, plain, Retinoids for topical use in acne, Other nasal preparations
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerRising Pharma Holdings, Inc.
Application holderCASPER PHARMA LLC
FDA applicationNDA006823 (NDA)
Labeler code64980
First marketedFeb 2026
Product typeHuman Prescription Drug
Portfolio523 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name AQUASOL A 100,000 UNIT/2 ML VL Ingredient Vitamin A Palmitate
📖 What it is MedlinePlus · NLM

Vitamin A is used as a dietary supplement when the amount of vitamin A in the diet is not enough. People most at risk for vitamin A deficiency are those with a limited variety of food in their diet and in those with cystic fibrosis (an inborn disease that causes problems with breathing, digestion, and reproduction) and malabsorption problems (problems absorbing food). Vitamin A is used to prevent and treat xerophthalmia (unable to see in low light) and night blindness. Vitamin A is in a class of medications called an antioxidant. It is needed by the body to help with vision, reproduction, cell...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Great question. Aquasol A injection is specifically for situations where you can't absorb or take vitamin A by mouth — for example, if you're dealing with severe nausea or vomiting...
  • Why would I need a vitamin A injection instead of just taking a supplement by mouth?
  • Yes, it can — and this is one of the most important things to know about vitamin A. Too much over time leads to a condition called hypervitaminosis A, which can affect your liver,...
  • This is a really important question. At the amounts found in a normal diet or standard prenatal vitamins, vitamin A is fine. But high-dose vitamin A — above the recommended dietary...
📖 Read our full Vitamin A guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII HM4YQM8WRC
    Chlorobutanol is a colorless crystalline chemical used as a preservative in medicines. It prevents bacterial and fungal growth to maintain product safety and shelf life.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
AQUASOL A Parenteral 15 mg/mLthis 64980-0721-02 Rising 1 vial — — FDA listed —
Aquasol A 15 mg/mL 70199-0026-11 Casper 1 vial — — Discontinued —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2026
On the market since
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
64980-0721-02 You're viewing this 1 VIAL, SINGLE-DOSE in 1 CARTON (64980-721-02) / 2 mL in 1 VIAL, SINGLE-DOSE 2026-02-27 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 64980-721-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 64980-0721-02, written without dashes as 64980072102. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 64980-0721-02, the first segment (64980) is the labeler code FDA assigned to Rising Pharma Holdings, Inc.; the middle segment (0721) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Rising Pharma Holdings, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Rising Pharma Holdings, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 110 words ▾

INDICATIONS Retinyl palmitate injection is effective for the treatment of vitamin A deficiency. The parenteral administration is indicated when the oral administration is not feasible as in anorexia, nausea, vomiting, pre- and postoperative conditions, or it is not available as in the “Malabsorption Syndrome” with accompanying steatorrhea. Pediatric Use: Vitamin A treatment for deficiency states has been recognized as an especially effective and important therapy in the pediatric population.

Vitamin A supplementation for deficiency states in this population has been addressed by the Committee on Clinical Practice Issues of the American Society for Clinical Nutrition, by the American Society for Parenteral and Enteral Nutrition, and by the World Health Organization.

⏱️ Dosage and Administration 142 words ▾

DOSAGE AND ADMINISTRATION For intramuscular use. I. Adults 100,000 Units daily for three days followed by 50,000 Units daily for two weeks.

II. Pediatric patients 1 to 8 years old 17,500 to 35,000 Units daily for 10 days. III.

Infants 7,500 to 15,000 Units daily for 10 days. Follow-up therapy with an oral therapeutic multivitamin preparation, containing 10,000 to 20,000 Units vitamin A for adults and for pediatric patients over 8 years old, and 5,000 to 10,000 Units for infants and other pediatric patients under 8 years old, is recommended daily for two months. Low birth-weight infants may require additional retinyl palmitate though the exact dosing in these pediatric patients has not been established.

In malabsorption, the parenteral route must be used for an equivalent preparation. Poor dietary habits should be corrected and an abundant and well-balanced dietary intake should be prescribed.

⛔ Contraindications 136 words ▾

CONTRAINDICATIONS The intravenous administration. Hypervitaminosis A. Sensitivity to any of the ingredients in this preparation.

Use in Pregnancy: Safety of amounts exceeding 6,000 Units of vitamin A daily during pregnancy has not been established at this time. The use of vitamin A in excess of the recommended dietary allowance may cause fetal harm when administered to a pregnant woman. Animal reproduction studies have shown fetal abnormalities associated with overdosage in several species.

Malformations of the central nervous system, the eye, the palate, and the urogenital tract are recorded. Vitamin A in excess of the recommended dietary allowance is contraindicated in women who are or may become pregnant. If vitamin A is used during pregnancy, or if the patient becomes pregnant while taking vitamin A, the patient should be apprised of the potential hazard to the fetus.

⚠️ Warnings 33 words ▾

WARNINGS Avoid overdosage. Keep out of the reach of children. Pediatric Use: Polysorbates have been associated with E-Ferol syndrome (thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension and metabolic acidosis) in low birthweight infants.

🤒 Adverse Reactions 55 words ▾

ADVERSE REACTIONS See OVERDOSAGE section. Anaphylactic shock and death have been reported using the intravenous route. Allergic reactions have been reported rarely with administration of AQUASOL A ® Parenteral including one case of an anaphylactoid type reaction. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🆘 Overdosage 204 words ▾

OVERDOSAGE The following amounts have been found to be toxic orally. Toxicity manifestations depend on the age, dosage, size, and duration of administration. Acute toxicity — single dose (25,000 Units/kg body weight) Infant: 350,000 Units Adult: Over 2 million Units Chronic toxicity (4,000 Units/kg body weight for 6 to 15 months) Infants 3 to 6 months old: 18,500 Units (water dispersed)/day for 1 to 3 months.

Adult: 1 million Units daily for three days; 50,000 Units daily for longer than 18 months; 500,000 Units daily for two months. Hypervitaminosis A Syndrome: 1. General manifestations: Fatigue, malaise, lethargy, abdominal discomfort, anorexia, and vomiting.

2. Specific manifestations: a. Skeletal: hepatotoxicity, hard tender cortical thickening over the radius and tibia, migratory arthralgia, slow growth, and premature closure of the epiphysis leading to arrested bone growth in children. b.

Central Nervous System: irritability, headache, and increased intracranial pressure as manifested by bulging fontanels, papilledema, and exophthalmos. c. Dermatologic: fissures of the lips, drying and cracking of the skin, alopecia, scaling, massive desquamation, and increased pigmentation. d. Systemic: hypomenorrhea, hepatosplenomegaly, hepatotoxicity, jaundice, leukopenia, retinyl palmitate plasma level over 1,200 Units/100 mL.

The treatment of hypervitaminosis A consists of immediate withdrawal of the vitamin along with symptomatic and supportive treatment.

🧬 Clinical Pharmacology 173 words ▾

CLINICAL PHARMACOLOGY Beta-carotene, retinol, and retinal have effective and reliable vitamin A activity. Retinal and retinol are in chemical equilibrium in the body and have equivalent antixerophthalmic activity. Retinal combines with the rod pigment, opsin, in the retina to form rhodopsin, necessary for visual dark adaptation.

Vitamin A prevents retardation of growth and preserves the epithelial cells' integrity. Normal adult liver storage is sufficient to satisfy two years' requirements of vitamin A. Vitamin A is readily absorbed from the gastrointestinal tract, where the biosynthesis of vitamin A from beta-carotene takes place.

Vitamin A absorption requires bile salts, pancreatic lipase, and dietary fat. It is transported in the blood to the liver by the chylomicron fraction of the lymph. Vitamin A is stored in Kupffer cells of the liver mainly as the palmitate.

Normal serum vitamin A is 80–300 Units per 100 mL (plasma range is 30–70 mcg per dl) and for carotenoids 270–753 Units per 100 mL. The normal adult liver contains approximately 100 to 300 micrograms per gram, mostly as retinol palmitate.

📦 How Supplied / Storage and Handling 67 words ▾

HOW SUPPLIED AQUASOL A ® Parenteral (Water-Miscible Retinyl Palmitate) is available as: Unit of Sale Concentration Each NDC 64980-721-02 Carton of 1 50,000 USP units/mL (15 mg retinol/mL) NDC 64980-721-02 2 mL Single-Dose Vial Store at 2° to 8°C (36° to 46°F). Do not freeze. Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Made in India Code No.: TN/DRUGS/616/1996 Issued: 01/2026 PIA72102-00 PLF295 US/LF/171 V01

📋 Description 114 words ▾

DESCRIPTION AQUASOL A ® Parenteral (Water-Miscible Retinyl Palmitate) provides 50,000 USP Units of vitamin A per mL as retinol (C 20 H 30 O) in the form of retinyl palmitate, a light yellow to amber oil. Contains 0.5% chlorobutanol as preservative; 12% polysorbate 80, 0.1% citric acid, and sodium hydroxide to adjust pH. The structural formula of retinol is: Ordinarily oil-soluble, the retinyl palmitate in this product has been water solubilized by special processing* and is available in a water solution for intramuscular injection.

One USP Unit is equivalent to one international unit (IU) and to 0.3 mcg of retinol or 0.6 mcg of betacarotene. *Oil-soluble retinyl palmitate water solubilized with polysorbate 80. aquasol-struc

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 64980-0712-30 · Rising 64980-0722-01 · Rising →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.