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Loratadine 5 mg/5mL Solution

by BluePoint Laboratories · 1 BOTTLE in 1 CARTON (68001-449-98) / 120 mL in 1 BOTTLE
NDC 68001-0449-98
🏷️ FDA NDC (as labeled) 68001-449-98 billing pads the product segment with a zero
OTC Generic 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 →

🆔 Identity & classification

FDA NDC (as labeled) 68001-449-98
Product NDC 68001-449
11-digit billing NDC 68001044998
NCPDP billing unit ML — per mL (volume)
RxCUI 692783
UNII 7AJO3BO7QN
Application # ANDA208931
SPL Set ID ab820f80-b5fc-7896-e053-2995a90a4b1c
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-07-31
Route ORAL
Dosage form SOLUTION
Substance LORATADINE
GPI-14 41550030002020
GPI class Loratadine
GCN Seq No 018697
GCN 60562
HICL code 007605
Ingredient (HICL) Loratadine
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2Q
Therapeutic class — specific (HIC3) Antihistamines - 2Nd Generation
AHFS code 04:08.00.00
AHFS class Second Generation Antihistamines
FDB label name LORATADINE 5 MG/5 ML SOLUTION
FDB brand name Loratadine
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 68001-449-98 — 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 → 68001-0449-98. 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 Other antihistamines for systemic use class.

Drug family (ATC) Other antihistamines for systemic use
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

LabelerBluePoint Laboratories
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA208931 (ANDA)
Labeler code68001
First marketedJul 2020
Product typeHuman Otc Drug
Portfolio347 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 LORATADINE 5 MG/5 ML SOLUTION Ingredient Loratadine
📖 What it is MedlinePlus · NLM

Loratadine is used to treat allergy symptoms: sneezing runny nose itching of the nose or throat red, itchy, or watery eyes Loratadine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Loratadine is an antihistamine that temporarily relieves common allergy symptoms — things like a runny nose, sneezing, itchy or watery eyes, and an itchy nose or throat. It works f...
  • When taken as directed, loratadine is considered non-drowsy for most people. However, if you take more than the recommended daily amount, drowsiness can happen. So stick to the dos...
  • It depends on the age. Children 6 and older can take standard adult doses of most forms. Children 2 to under 6 can use the oral solution or chewable tablets, but at a lower amount....
  • You should check with your doctor before taking loratadine if you have liver or kidney disease. Your doctor may need to adjust your dose. It's not necessarily off-limits, but it's...
📖 Read our full Loratadine guide →
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.

💊 What it looks like

Color yellow
FlavorGrape
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 6X543N684K
    A natural flavoring derived from grapes that enhances taste appeal. It's used in medicines to improve flavor and make medications more palatable, especially for children or patients who need better taste acceptance.
  • UNII D65DG142WK
    Maltitol is a sugar alcohol made by hydrogenating maltose. It's used as a sweetener and filler in medicines to improve taste and add bulk to tablets and capsules.
  • UNII E4GA8884NN
    Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 4VON5FNS3C
    Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.
  • UNII 593YOG76RN
    A salt made from sodium and phosphate that helps regulate acidity and maintain proper pH balance in the medicine. It also acts as a buffer to keep the product stable.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesartificial flavors, ascorbic acid, glycerin, maltitol, monobasic sodium phosphate monohydrate, phosphoric acid, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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 $0.041 $4.97 / 120 ml
Medicaid paysCMS SDUD · 12 mo $0.0816 $9.79 / 120 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.047 $0.039
▲ Up 6% 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Sense childrens allergy relief 5 mg/5mL 00113-0671-26 L. 1 bottle $0.041 — Availability likely —
Childrens Loratadine Oral 5 mg/5mL 00904-6767-20 Major 1 bottle $0.041 — Availability likely —
Good Neighbor Pharmacy Childrens Loratadine 5 mg/5mL 24385-0531-26 AmerisourceBergen 1 bottle $0.041 — Availability likely —
good neighbor pharmacy childrens loratadine 5 mg/5mL 46122-0787-34 Amerisource 1 bottle $0.041 — Availability likely —
Loratadine 5 mg/5mL 54838-0558-40 Lannett 120 ml $0.041 — Availability likely —
Loratadine 5 mg/5mLthis 68001-0449-98 BluePoint 1 bottle $0.041 — Availability likely —
Loratadine 5 mg/5mL 69230-0322-12 Camber 1 bottle $0.041 — Availability likely —
leader childrens allergy relief 5 mg/5mL 70000-0473-01 Cardinal 1 bottle $0.041 — Availability likely —
Loratadine 5 mg/5mL 70677-1057-01 STRATEGIC 1 bottle $0.041 — Availability likely —
Childrens Loratadine Sugar Free 5 mg/5mL 70677-1058-01 STRATEGIC 1 bottle $0.041 — Availability likely —
Sunmark childrens loratadine 5 mg/5mL 49348-0636-34 Strategic 1 bottle $0.042 — FDA listed +3%
Loratadine 5 mg/5mL 70000-0125-01 Cardinal 1 bottle $0.044 — Availability likely +5%
good sense childrens allergy relief 5 mg/5mL 00113-1719-06 L. 1 bottle — — FDA listed —
Loratadine 5 mg/5mL 00363-0771-01 WALGREEN 1 bottle — — FDA listed —
Childrens Walitin 5 mg/5mL 00363-2108-08 Walgreen 1 bottle — — FDA listed —
Childrens Loratadine Sugar Free 5 mg/5mL 00363-2131-08 Walgreen 1 bottle — — FDA listed —
Claritin Allergy 1 mg/mL 11523-0101-01 Bayer 1 bottle — — FDA listed —
Children Claritin Allergy 5 mg/5mL 11523-4360-01 Bayer 1 bottle — — FDA listed —
childrens allergy relief 5 mg/5mL 11822-0620-00 Rite 1 bottle — — FDA listed —
Childrens Loratadine Oral 5 mg/5mL 17856-6767-01 Atlantic 72 cups — — FDA listed —
Loratadine 5 mg/5mL 21130-0042-24 Better 1 bottle — — FDA listed —
Good Neighbor Pharmacy Childrens Loratadine 5 mg/5mL 24385-0543-26 AmerisourceBergen 1 bottle — — Discontinued —
Loratadine 5 mg/5mL 30142-0062-24 KROGER 1 bottle — — FDA listed —
childrens allergy relief 5 mg/5mL 30142-0723-00 Kroger 1 bottle — — Discontinued —
topcare childrens allergy 5 mg/5mL 36800-0608-26 Topco 1 bottle — — FDA listed —
Childrens Loratadine Sugar Free 5 mg/5mL 37808-0131-08 H 1 bottle — — FDA listed —
Equaline Childrens Allergy Relief 5 mg/5mL 41163-0633-26 United 1 bottle — — FDA listed —
childrens allergy relief 5 mg/5mL 41250-0716-00 Meijer, 1 bottle — — FDA listed —
Childrens Loratadine Sugar Free 5 mg/5mL 41520-0131-08 American 1 bottle — — FDA listed —
Childrens Allergy 5 mg/5mL 49035-0538-08 Wal-Mart 1 bottle — — FDA listed —
equate childrens allergy 5 mg/5mL 49035-0611-34 Wal-Mart 1 bottle — — FDA listed —
Loratadine 5 mg/5mL 50090-1454-00 A-S 120 ml — — FDA listed —
Childrens Loratadine Oral 5 mg/5mL 50090-7516-00 A-S 1 bottle — — FDA listed —
Childrens Allergy Relief 5 mg/5mL 51316-0611-34 CVS 1 bottle — — FDA listed —
Childrens Loratadine 5 mg/5mL 51672-2073-04 Sun 1 bottle — — FDA listed —
Childrens Loratadine 5 mg/5mL 51672-2085-01 Sun 1 bottle — — FDA listed —
Childrens Loratadine Sugar Free 5 mg/5mL 51672-2108-01 Sun 1 bottle — — FDA listed —
Childrens Loratadine Sugar Free 5 mg/5mL 51672-2131-01 Sun 1 bottle — — FDA listed —
Loratadine 5 mg/5mL 54838-0554-40 Lannett 120 ml — — FDA listed —
dg health childrens allergy 5 mg/5mL 55910-0611-26 Dolgencorp, 1 bottle — — FDA listed —
childrens allergy 5 mg/5mL 56062-0092-08 Publix 1 bottle — — FDA listed —
Loratadine 5 mg/5mL 58602-0423-11 Aurohealth 1 bottle — — FDA listed —
Childrens Loratadine 5 mg/5mL 62011-0305-01 Strategic 1 bottle — — FDA listed —
welby childrens allergy relief 5 mg/5mL 64024-0023-26 Aldi 1 bottle — — FDA listed —
Good Sense childrens allergy relief 5 mg/5mL 68071-3904-04 NuCare 1 bottle — — FDA listed —
Loratadine 5 mg/5mL 68071-4451-04 NuCare 120 ml — — FDA listed —
Childrens Loratadine Sugar Free 5 mg/5mL 68788-8286-01 Preferred 1 bottle — — FDA listed —
Good Sense childrens allergy relief 5 mg/5mL 68788-8657-01 Preferred 1 bottle — — FDA listed —
Childrens Allergy 5 mg/5mL 69842-0337-26 CVS 1 bottle — — FDA listed —
Childrens Allergy 5 mg/5mL 69842-0535-08 CVS 1 bottle — — FDA listed —
basic care childrens allergy relief 5 mg/5mL 72288-0511-26 Amazon.com 1 bottle — — Discontinued —
Up And Up Childrens Allergy 5 mg/5mL 82442-0207-26 Target 1 bottle — — 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

🏛️
2020
On the market since
Jul 2020
📍
2026
Currently FDA-listed
6 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 68001-0449-98, 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 – Q1 2026 · 5 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
52K
Units reimbursed last 4 qtrs
8.2M
Gross reimbursed last 4 qtrs
$668.8K
Avg / prescription
$12.86
Avg / unit
$0.0816
Latest quarter Q1 2026
11.1KRx
Medicaid pays / mL
$0.0816
gross reimbursed
vs
NADAC / mL
$0.0414
acquisition cost
=
Spread
+$0.0402
+97% vs cost
What Medicaid paid per mL (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 ⓘ
42% FFS 58% MCO
Fee-for-service · 22,096 Rx Managed care · 29,928 Rx
State Medicaid map
Alaska: no data reported AK Maine: 8,505 units · 610 per 100k residents ME Washington: 13,070 units · 167 per 100k residents WA Idaho: 7,245 units · 369 per 100k residents ID Montana: 2,040 units · 180 per 100k residents MT North Dakota: no data reported ND Minnesota: 38,223 units · 666 per 100k residents MN Wisconsin: 33,493 units · 567 per 100k residents WI Michigan: 380,561 units · 3,792 per 100k residents MI New York: 2,583,236 units · 13,199 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 17,350 units · 410 per 100k residents OR Nevada: 24,616 units · 771 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 21,791 units · 679 per 100k residents IA Illinois: 31,110 units · 248 per 100k residents IL Indiana: 87,741 units · 1,279 per 100k residents IN Ohio: 203,538 units · 1,727 per 100k residents OH Pennsylvania: 272,955 units · 2,106 per 100k residents PA New Jersey: 525,534 units · 5,657 per 100k residents NJ Massachusetts: 102,511 units · 1,464 per 100k residents MA California: no data reported CA Utah: no data reported UT Colorado: 7,215 units · 123 per 100k residents CO Nebraska: 297 units · 15.0 per 100k residents NE Missouri: 259,582 units · 4,190 per 100k residents MO Kentucky: 439,213 units · 9,704 per 100k residents KY West Virginia: no data reported WV Virginia: 124,270 units · 1,426 per 100k residents VA Maryland: 98,054 units · 1,587 per 100k residents MD Connecticut: 42,338 units · 1,171 per 100k residents CT Rhode Island: 4,485 units · 410 per 100k residents RI Arizona: 1,995 units · 26.8 per 100k residents AZ New Mexico: 25,342 units · 1,199 per 100k residents NM Kansas: 48,084 units · 1,636 per 100k residents KS Arkansas: 301,763 units · 9,839 per 100k residents AR Tennessee: 69,793 units · 979 per 100k residents TN North Carolina: 10,530 units · 97.2 per 100k residents NC South Carolina: 161,381 units · 3,004 per 100k residents SC Delaware: 30,130 units · 2,922 per 100k residents DE Oklahoma: 522 units · 12.9 per 100k residents OK Louisiana: 131,074 units · 2,866 per 100k residents LA Mississippi: 119,955 units · 4,080 per 100k residents MS Alabama: 60,120 units · 1,177 per 100k residents AL Georgia: 1,069,811 units · 9,700 per 100k residents GA D.C.: 21,105 units · 3,108 per 100k residents DC Hawaii: 24,920 units · 1,737 per 100k residents HI Texas: 645,063 units · 2,115 per 100k residents TX Florida: 13,178 units · 58.3 per 100k residents FL
Units reimbursed · per 100k residents
12.913,199
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 New York 13,199 /100k
2 Arkansas 9,839 /100k
3 Kentucky 9,704 /100k
4 Georgia 9,700 /100k
5 New Jersey 5,657 /100k
6 Missouri 4,190 /100k
7 Mississippi 4,080 /100k
8 Michigan 3,792 /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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68001-0449-98 You're viewing this 1 BOTTLE in 1 CARTON (68001-449-98) / 120 mL in 1 BOTTLE 2020-07-31 Active

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 26 words ▾

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat

⏱️ Dosage and Administration 64 words ▾

Directions use only with enclosed dosing cup mL= milliliter adults and children 6 years and over 10mL daily; do not take more than 10mL in 24 hours children 2 to under 6 years of age 5mL daily; do not take more than 5mL in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor

⚠️ Warnings 20 words ▾

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

📦 Storage and Handling 32 words ▾

Other information each 5mLcontains : sodium 6 mg do not use if carton is opened, or if cap safety seal is broken or missing. store at 20° to 25°C (68° to 77°F)

🧪 Active Ingredient 12 words ▾

Drug Facts Active ingredient (in each 5 mL) Loratadine USP 5 mg

🧪 Inactive Ingredients 24 words ▾

Inactive ingredients artificial flavors, ascorbic acid, glycerin, maltitol, monobasic sodium phosphate monohydrate, phosphoric acid, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose.

🎯 Purpose 2 words ▾

Purpose Antihistamine

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