NDC 45802-0419-26 — Ammonium Lactate 12 g/100g Lotion, 400 g

🆔 Identity & classification

FDA NDC (as labeled) 45802-419-26

Product NDC 45802-419

11-digit billing NDC 45802041926

NCPDP billing unit GM — per gram (weight)

RxCUI 197362

UNII 67M901L9NQ

Application # ANDA075570

SPL Set ID dc3a6462-0f2c-4306-b5ef-c7b47395e959

Established class (EPC) alpha-Hydroxy Acid

Chemical class Hydroxy Acids

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2006-06-20

Route TOPICAL

Dosage form LOTION

Substance AMMONIUM LACTATE

GCN Seq No 005826

GCN 20941

HICL code 015560

Ingredient (HICL) Ammonium Lactate

HIC1 code L

Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue

HIC2 code L2

Therapeutic class — intermediate (HIC2) Emollients

HIC3 code L2A

Therapeutic class — specific (HIC3) Emollients

AHFS code 84:24.04.00

AHFS class Basic Lotions And Liniments

FDB label name AMMONIUM LACTATE 12% LOTION

FDB brand name Ammonium Lactate

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 45802-419-26 — 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 → 45802-0419-26. 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 Organic acids class.

Drug family (ATC) Organic acids

How it works Acidifying Activity

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

LabelerPadagis Israel Pharmaceuticals Ltd

Application holderPADAGIS ISRAEL PHARMACEUTICALS LTD

FDA applicationANDA075570 (ANDA)

Labeler code45802

First marketedJun 2006

Product typeHuman Prescription Drug

Portfolio175 products on file

🔎 All NDCs from Padagis Israel Pharmaceuticals Ltd

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 AMMONIUM LACTATE 12% LOTION Ingredient Ammonium Lactate

Patient education

📘 MedlinePlus patient leaflet ↗

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 system	Per g	Per package
Retail pharmacies payNADAC · weekly	$0.072	$28.76 / 400 g
Medicaid paysCMS SDUD · 12 mo	$0.0615	$24.60 / 400 g
Medicare drug plans payPart D · Q2 2026	$0.0857	$34.28 / 400 g

NADAC price history (per g) — tap or hover for the price & month

▼ Down 12% over the last 24 months.

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Ammonium Lactate 12 g/100g 45802-0493-26	Padagis	385 g	$0.068	AB	Availability likely	save 5%
Ammonium Lactate 120 mg/g 51672-1300-05	Sun	225 g	$0.071	AB	Availability likely	save 2%
Ammonium Lactate 12 g/100gthis 45802-0419-26	Padagis	400 g	$0.072	AB	Availability likely	—
Ammonium Lactate 120 mg/g 50090-6587-00	A-S	225 g	—	AB	FDA listed	—
Ammonium Lactate 12 g/100g 63629-8610-01	Bryant	225 g	—	AB	FDA listed	—
Ammonium Lactate 12 g/100g 63629-8611-01	Bryant	400 g	—	AB	FDA listed	—
Ammonium Lactate 12 g/100g 72162-1407-02	Bryant	225 g	—	AB	FDA listed	—
Ammonium Lactate 12 g/100g 63629-8609-01	Bryant	385 g	—	AB	FDA listed	—
Ammonium Lactate 12 g/100g 72162-1413-02	Bryant	2 tubes	—	AB	FDA listed	—
Ammonium Lactate 12 g/100g 63629-8608-01	Bryant	2 tubes	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

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

🏛️

2006

On the market since

Jun 2006

📍

2026

Currently FDA-listed

20 years listed

🔓

·

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 45802-0419-26, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

44.5K

Units reimbursed last 4 qtrs

17.7M

Gross reimbursed last 4 qtrs

$1.09M

Avg / prescription

$24.48

Avg / unit

$0.0615

Latest quarter Q4 2025

9.7KRx

Medicaid pays / g

$0.0615

gross reimbursed

vs

NADAC / g

$0.0719

acquisition cost

=

Spread

−$0.0104

-14% vs cost

What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

19% FFS 81% MCO

Fee-for-service · 8,302 Rx Managed care · 36,228 Rx

State Medicaid map

Units reimbursed · per 100k residents

14058,070

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 D.C. 58,070 /100k

2 Connecticut 27,879 /100k

3 Nevada 23,091 /100k

4 New Jersey 22,482 /100k

5 West Virginia 18,282 /100k

6 Pennsylvania 13,182 /100k

7 Ohio 13,170 /100k

8 Florida 12,539 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

225 gs45802-0419-54 47,852 Rx · $720,338

400 gs this page45802-0419-26 44,530 Rx · $1,090,166

Drug total (last 4 qtrs): 92,382 Rx · 28,690,481 units · $1,810,504 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Ammonium Lactate — the program that covers self-administered drugs. 3 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ammonium Lactate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$7.57M

Claims incl. refills

359.4K

Beneficiaries

250K

Spend / beneficiary

$30.29

Spend / claim

$21.07

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Ammonium Lactate — the ingredient across all brands.

Top reported reactions

Fatigue149

Pain148

Diarrhoea140

Chronic Kidney Disease127

Nausea126

Dyspnoea115

Rash110

Reporter sex

Male · 41%

Female · 59%

Unknown · 0%

Serious outcomes

Disabling44

Life-threatening31

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
45802-0419-26 You're viewing this	400 g in 1 BOTTLE, PLASTIC (45802-419-26)	$0.0719 / g	$28.76	2006-06-20	Active
45802-0419-54	225 g in 1 BOTTLE, PLASTIC (45802-419-54)	$0.0708 / g	$15.93	2006-06-20	Active

You're viewing the largest of 2 pack sizes for this product.

This pack accounts for about 48% of this product's recent Medicaid fills; most go to the 225 gs pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 45802-0419-26?

NDC 45802-0419-26 contains 400 g — 400 g in 1 bottle, plastic.

What is the difference between NDC 45802-0419-26 and NDC 45802-0419-54?

Both are Ammonium Lactate 12 g/100g Lotion — the drug itself is identical. NDC 45802-0419-26 is the 400 g package, while NDC 45802-0419-54 is the 225 g package. Per-g NADAC also differs: $0.0719 here vs $0.0708 for the 225 g pack.

What NDC number is used to bill for this package of Ammonium Lactate 12 g/100g Lotion?

Bill NDC 45802-0419-26 — the 11-digit billing format is 45802041926. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 31 words ▾

INDICATIONS AND USAGE Ammonium Lactate Lotion, 12% is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris, and for the temporary relief of itching associated with these conditions.

⏱️ Dosage and Administration 23 words ▾

DOSAGE AND ADMINISTRATION Shake well. Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.

⛔ Contraindications 21 words ▾

CONTRAINDICATIONS Ammonium Lactate Lotion, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.

⚠️ Warnings 41 words ▾

WARNING Sun exposure (natural or artificial sunlight) to areas of the skin treated with Ammonium Lactate Lotion, 12% should be minimized or avoided (see PRECAUTIONS ). The use of Ammonium Lactate Lotion, 12% should be discontinued if any hypersensitivity is observed.

🤒 Adverse Reactions 77 words ▾

ADVERSE REACTIONS The most frequent adverse experiences in patients with xerosis are transient stinging (1 in 30 patients), burning (1 in 30 patients), erythema (1 in 50 patients) and peeling (1 in 60 patients). Other adverse reactions which occur less frequently are irritation, eczema, petechiae, dryness, and hyperpigmentation. Due to the more severe initial skin conditions associated with ichthyosis, there was a higher incidence of transient stinging, burning and erythema (each occurring in 1 in 10 patients).

🤰 Pregnancy 101 words ▾

Pregnancy: Teratogenic effects: Pregnancy Category B – Animal reproduction studies have been performed in rats and rabbits at doses up to 0.7 and 1.5 times the human dose, respectively (600 mg/kg/day, corresponding to 3600 mg/m 2 /day in the rat and 7200 mg/m 2 /day in the rabbit) and have revealed no evidence of impaired fertility or harm to the fetus due to ammonium lactate formulations. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Ammonium Lactate Lotion, 12% should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 22 words ▾

Pediatric Use - Safety and effectiveness of ammonium lactate have been demonstrated in infants and children. No unusual toxic effects were reported.

🧓 Geriatric Use 56 words ▾

Geriatric Use - Clinical studies of ammonium lactate lotion, 12% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious.

🆘 Overdosage 22 words ▾

OVERDOSAGE The oral administration of ammonium lactate to rats and mice showed this drug to be practically non-toxic (LD 50 >15 mL/kg).

🧬 Clinical Pharmacology 95 words ▾

CLINICAL PHARMACOLOGY Lactic acid is an alpha-hydroxy acid, it is a normal constituent of tissues and blood. The alpha-hydroxy acids (and their salts) may act as humectants when applied to the skin. This property may influence hydration of the stratum corneum.

In addition, lactic acid, when applied to the skin, may act to decrease corneocyte cohesion. The mechanism(s) by which this is accomplished is not yet known. An in vitro study of percutaneous absorption of ammonium lactate lotion, 12% using human cadaver skin indicates that approximately 5.8% of the material was absorbed after 68 hours.

📦 How Supplied / Storage and Handling 34 words ▾

HOW SUPPLIED Ammonium Lactate Lotion, 12% is available as follows: 225 g bottle (NDC 45802- 419 -54) 400 g bottle (NDC 45802- 419 -26) STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

📦 Storage and Handling 10 words ▾

STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

📋 Description 72 words ▾

DESCRIPTION *Ammonium Lactate Lotion, 12% specially formulates 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate to provide a lotion pH of 4.5 - 5.5. It also contains cetyl alcohol, fragrance, glycerin, glyceryl stearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, and purified water. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula: structural formula

💬 Information for Patients 135 words ▾

Information for Patients Patients using Ammonium Lactate Lotion, 12% should receive the following information and instructions: 1. This medication is to be used as directed by the physician, and should not be used for any disorder other than for which it was prescribed. It is for external use only.

Avoid contact with eyes, lips, or mucous membranes. 2. Patients should minimize or avoid use of this product on areas of the skin that may be exposed to natural or artificial sunlight, including the face.

If sun exposure is unavoidable, clothing should be worn to protect the skin. 3. This medication may cause transient stinging or burning when applied to skin with fissures, erosions, or abrasions (for example, after shaving the legs).

4. If the skin condition worsens with treatment, the medication should be promptly discontinued.

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

fertility: The natural ability to become pregnant or to father a child.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

petechiae: Tiny flat red or purple spots on the skin caused by small amounts of bleeding underneath.

pregnancy category: An older letter rating (A, B, C, D, or X) once used to describe a medicine's possible risk during pregnancy.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

🔗 Related NDC lookups

🧪 All Ammonium Lactate NDCsSame ingredient 🏭 All Padagis labeler NDCsLabeler code 45802

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Emollients.

Lanolin 53329-0042-44 Vitamins A And D 53329-0067-04 Glycerin 67777-0233-02 Mineral Oil/Petrolatum,White 70942-0200-03

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.