Pseudoephedrine hydrochloride 120 mg Tablet, Film Coated, 10-count — NDC 70677-1019-01 package photo

Pseudoephedrine hydrochloride 120 mg Tablet, Film Coated, 10-count

by STRATEGIC SOURCING SERVICES LLC · 1 BLISTER PACK in 1 CARTON (70677-1019-1) / 10 TABLET, FILM COATED in 1 BLISTER PACK
NDC 70677-1019-01
🏷️ FDA NDC (as labeled) 70677-1019-1 billing pads the package segment with a zero
This package
Contains10-count Cost per ea$0.2805 NADAC Per package$2.81 / 10 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.6172/unit — full pricing hub ↓
Also comes in: 10 tablets 70677-1019-02
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) 70677-1019-1
Product NDC 70677-1019
11-digit billing NDC 70677101901
NCPDP billing unit EA — each (per item)
RxCUI 1049154
UNII 6V9V2RYJ8N
UPC 0010939955371
Application # ANDA077442
SPL Set ID 3bf95c58-4fd9-4caa-a54f-2e61a5eacae8
Established class (EPC) alpha-Adrenergic Agonist
Mechanism of action Adrenergic alpha-Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-08-10
Route ORAL
Dosage form TABLET, FILM COATED
Substance PSEUDOEPHEDRINE HYDROCHLORIDE
GPI-14 42101020107405
GCN Seq No 016937
GCN 26901
HICL code 002091
Ingredient (HICL) Pseudoephedrine Hcl
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B6
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Cont3)
HIC3 code B6V
Therapeutic class — specific (HIC3) Decongestants, Oral
AHFS code 12:12.12.00
AHFS class Alpha- And Beta-Adrenergic Agonists
FDB label name FT NASAL DECONGEST ER 120 MG
FDB brand name Nasal Decongestant
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 70677-1019-1 — a 5-4-1 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 package segment → 70677-1019-01. 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 alpha-Adrenergic Agonist class.

Pharmacologic class alpha-Adrenergic Agonist
Drug family (ATC) Sympathomimetics
How it works Adrenergic alpha-Agonists
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

LabelerSTRATEGIC SOURCING SERVICES LLC
Application holderSUN PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA077442 (ANDA)
Labeler code70677
First marketedAug 2023
Product typeHuman Otc Drug
Portfolio316 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 FT NASAL DECONGEST ER 120 MG Ingredient Pseudoephedrine Hcl
📖 What it is MedlinePlus · NLM

Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Pseudoephedrine is a decongestant — it works to temporarily shrink the swollen blood vessels inside your nasal passages and sinuses, which helps open things up so you can breathe m...
  • What exactly does pseudoephedrine do for my congestion?
  • Yes, it does. The regular tablets and Zephrex D capsules are taken every 4 to 6 hours, while extended-release tablets like Sudafed Sinus Congestion 12 Hour or Good Sense Suphedrine...
  • Does it matter which product or form I pick?
📖 Read our full Pseudoephedrine 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 white
ShapeCapsule
Imprint204
Size18 mm
ScoringNot scored
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 D5340Y2I9G
    Castor oil is a natural plant-based oil used in medicines as a lubricant, laxative agent, and solvent. It helps medicine ingredients dissolve or flow smoothly and can aid bowel movement in formulations designed for that purpose.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

The official label also statescastor oil, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, magnesium stearate, titanium dioxide

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 DailyMedingredient 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 eaPer package
Retail pharmacies payNADAC · weekly $0.281 $2.81 / 10 tablets
Medicaid paysCMS SDUD · 12 mo $0.6172 $6.17 / 10 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Feb 2024 Feb 2026 May 2026 Aug 2026 $0.287 $0.263
▲ Up 2% over the last 10 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
Pseudoephedrine Hydrochloride 120 mg 62011-0306-01 STRATEGIC 10 tablets $0.274 FDA listed save 2%
leader 12 hour nasal decongestant 120 mg 70000-0475-01 Cardinal 1 tablet $0.276 FDA listed save 1%
Good Sense Suphedrine 12 Hour 120 mg 00113-0054-52 L. 1 tablet $0.281 Availability likely
sinus 12 hour 120 mg 00113-2017-60 L. 1 tablet $0.281 Availability likely
SudoGest 12 Hour 120 mg 00904-6754-15 Major 1 tablet $0.281 Availability likely
Pseudoephedrine hydrochloride 120 mg 00904-7409-15 Major 10 tablets $0.281 Availability likely
good neighbor pharmacy nasal decongestant 120 mg 24385-0054-52 Amerisource 1 tablet $0.281 Availability likely
pseudoephedrine hydrochloride 120 mg 45802-0107-52 Padagis 1 tablet $0.281 Availability likely
Pseudoephedrine hydrochloride 120 mg 51660-0204-21 Ohm 20 tablets $0.281 Availability likely
Pseudoephedrine hydrochloride 120 mg 51660-0492-21 Ohm 20 tablets $0.281 Availability likely
Pseudoephedrine Hydrochloride 120 mg 70000-0601-01 CARDINAL 20 tablets $0.281 Availability likely
12 Hour Nasal Decongestant 120 mg 70000-0656-01 CARDINAL 10 tablets $0.281 Availability likely
nasal decongestant 120 mg 70677-0001-01 Strategic 10 tablets $0.281 Availability likely
Pseudoephedrine hydrochloride 120 mgthis 70677-1019-01 STRATEGIC 10 tablets $0.281 Availability likely
Nasal Decongestant D 120 mg 00363-3301-52 Walgreen 1 tablet FDA listed
sinus pressure and congestion relief maximum strength 120 mg 11822-0650-06 Rite 1 tablet FDA listed
Pseudoephedrine HCl 120 mg 21130-0158-67 Better 10 tablets FDA listed
Pseudoephedrine Hydrochloride 120 mg 21130-0204-21 Safeway 20 tablets FDA listed
Pseudoephedrine hydrochloride 120 mg 30142-0967-20 The 20 tablets FDA listed
topcare 12 hour decongestant 120 mg 36800-0054-52 Topco 1 tablet FDA listed
Pseudoephedrine Hydrochloride 120 mg 37808-0007-69 HEB 20 tablets FDA listed
Equaline 12 Hour Decongestant 120 mg 41163-0054-60 United 1 tablet FDA listed
nasal decongestant 120 mg 41250-0809-52 Meijer 1 tablet FDA listed
CareOne Nasal and Sinus Decongestant 120 mg 41520-0429-52 American 1 tablet FDA listed
equate sinus 12 hour 120 mg 49035-0508-60 Wal-Mart 1 tablet FDA listed
Sudafed Sinus Congestion 12 Hour 120 mg 50090-4629-00 A-S 10 tablets FDA listed
Pseudoephedrine hydrochloride 120 mg 50090-5554-00 A-S 10 tablets FDA listed
Sudafed Sinus Congestion 12 Hour 120 mg 50580-0242-01 Kenvue 10 tablets FDA listed
sinus and nasal decongestant 120 mg 51316-0616-52 CVS 1 tablet FDA listed
Pseudoephedrine hydrochloride 120 mg 53943-0204-10 DISCOUNT 10 tablets FDA listed
nasal decongestant 120 mg 56062-0054-60 Publix 1 tablet FDA listed
Pseudoephedrine Hydrochloride 120 mg 56062-0204-21 Publix 20 tablets FDA listed
Pseudoephedrine HCl 120 mg 58602-0804-67 Aurohealth 10 tablets FDA listed
Pseudoephedrine Hydrochloride 120 mg 59779-0204-21 CVS 20 tablets FDA listed
12 Hour Nasal Decongestant 120 mg 59779-0703-52 CVS 1 tablet FDA listed
Pseudoephedrine Hydrochloride 120 mg 63868-0143-10 Chain 10 tablets FDA listed
Pseudoephedrine Hydrochloride 120 mg 68016-0204-69 Chain 10 tablets FDA listed
Pseudoephedrine hydrochloride 120 mg 68196-0204-20 SAM'S 10 tablets FDA listed
Leader 12 Hour Sinus Nasal Decongestant 120 mg 70000-0735-01 Cardinal 1 tablet FDA listed
Pseudoephedrine hydrochloride 120 mg 85766-0050-10 Sportpharm 10 tablets 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

🏛️
2023
On the market since
Aug 2023
📍
2026
Currently FDA-listed
3 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 70677-1019-01, 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
87
Units reimbursed last 4 qtrs
2.3K
Gross reimbursed last 4 qtrs
$1.4K
Avg / prescription
$16.58
Avg / unit
$0.6172
Latest quarter Q1 2026
28Rx
Medicaid pays / ea
$0.6172
gross reimbursed
vs
NADAC / ea
$0.2805
acquisition cost
=
Spread
+$0.3367
+120% vs cost
What Medicaid paid per ea (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
100% MCO
Fee-for-service · 0 Rx Managed care · 87 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 452 units · 22.9 per 100k residents NE Missouri: no data reported MO Kentucky: 1,885 units · 41.6 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
22.941.6
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 Kentucky 41.6 /100k
2 Nebraska 22.9 /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.
Drug total (last 4 qtrs): 87 Rx · 2,337 units · $1,442 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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 Pseudoephedrine Hydrochloride — the ingredient across all brands.

Top reported reactions

Pain6,310
Fatigue6,282
Abdominal Discomfort5,420
Systemic Lupus Erythematosus5,318
Rheumatoid Arthritis5,271
Rash5,268
Alopecia5,173

Age at onset

Neonate75
Infant8
Child110
Adolescent80
Adult3,977
Elderly1,974

Reporter sex

0 reports
Male · 27%
Female · 73%
Unknown · 0%

Serious outcomes

Hospitalization9,723
Disabling5,240
Death4,996
Life-threatening4,300
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,747 0
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 NDCDescription Per unit Per pack Marketing startStatus
70677-1019-01 You're viewing this 1 BLISTER PACK in 1 CARTON (70677-1019-1) / 10 TABLET, FILM COATED in 1 BLISTER PACK $0.2805 / ea $2.81 2023-08-10 Active
70677-1019-02 2 BLISTER PACK in 1 CARTON (70677-1019-2) / 10 TABLET, FILM COATED in 1 BLISTER PACK 2026-05-06 Active

Pack size FAQ

What quantity is in NDC 70677-1019-01?
NDC 70677-1019-01 is a 10-count package — 1 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of Pseudoephedrine hydrochloride 120 mg Tablet, Film Coated?
Bill NDC 70677-1019-01 — the 11-digit billing format is 70677101901. 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.

📄 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 23 words

Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure

⏱️ Dosage and Administration 40 words

Directions adults and children 12 years and over take 1 tablet every 12 hours do not take more than 2 tablets in 24 hours children under 12 years do not use this product in children under 12 years of age

⚠️ Warnings 145 words

Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland When using this product do not exceed recommended dosage Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

📦 Storage and Handling 32 words

Other information store at 59° to 77° F in a dry place. Protect from light TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

🧪 Active Ingredient 10 words

Active ingredient (in each tablet) Pseudoephedrine HCl, USP 120 mg

🧪 Inactive Ingredients 14 words

Inactive ingredients castor oil, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, magnesium stearate, titanium dioxide

🎯 Purpose 3 words

Purpose Nasal decongestant

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.