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Caffeine 200 mg Tablet, 16-count — NDC 70000-0409-01 package photo

Caffeine 200 mg Tablet, 16-count

by LEADER/ Cardinal Health 110, Inc. · 2 BLISTER PACK in 1 CARTON (70000-0409-1) / 8 TABLET in 1 BLISTER PACK
NDC 70000-0409-01
🏷️ FDA NDC (as labeled) 70000-0409-1 billing pads the package segment with a zero
OTC 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) 70000-0409-1
Product NDC 70000-0409
11-digit billing NDC 70000040901
NCPDP billing unit EA — each (per item)
RxCUI 198520
UNII 3G6A5W338E
UPC 0096295135251
Application # M011
SPL Set ID 7c4d61f7-9c6a-61ac-e053-2991aa0a9533
Established class (EPC) Central Nervous System Stimulant; Methylxanthine
Physiologic effect Central Nervous System Stimulation
Chemical class Xanthines
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-04-05
Route ORAL
Dosage form TABLET
Substance CAFFEINE
GPI-14 61300010000320
GPI class Caffeine
GCN Seq No 000033
GCN 00212
HICL code 000012
Ingredient (HICL) Caffeine
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A1
Therapeutic class — intermediate (HIC2) Cardiac Stimulants
HIC3 code A1B
Therapeutic class — specific (HIC3) Xanthines
AHFS code 28:20.32.00
AHFS class Respiratory And Cns Stimulants
FDB label name CAFFEINE 200 MG TABLET
FDB brand name Caffeine
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 70000-0409-1 — 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 → 70000-0409-01. 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 Central Nervous System Stimulant class.

Pharmacologic class Central Nervous System Stimulant, Methylxanthine
Drug family (ATC) Tests for gastric secretion, Other dermatologicals, Xanthine derivatives
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

LabelerLEADER/ Cardinal Health 110, Inc.
FDA applicationM011 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedApr 2019
Product typeHuman Otc Drug
Portfolio38 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 CAFFEINE 200 MG TABLET Ingredient Caffeine
📗 Our plain-language guide HelloPharmacist
  • Caffeine citrate is a prescription medicine given in the hospital to premature babies who have apnea of prematurity — that means they sometimes stop breathing for short periods, wh...
  • What exactly is caffeine citrate used for in babies, and is it safe?
  • The medical team will be monitoring your baby closely, but it helps to know the signs to watch for. The most serious concern is necrotizing enterocolitis (NEC) — a severe intestina...
  • What side effects should I watch for in my premature baby on caffeine citrate?
📖 Read our full Caffeine guide →
1
Nutrient depletion considerations

Caffeine (OTC drug) may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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
ShapeRound
Imprint212;212
Size11 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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII O7TSZ97GEP
    A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • 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 O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

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

The official label also statescorn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, dicalcium phosphate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silica

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 $0.085 $1.36 / 16 tablets
Medicaid paysCMS SDUD · 12 mo $0.1780 $2.85 / 16 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
Nov 2021 Aug 2022 Dec 2025 Aug 2026 $0.089 $0.063
▲ Up 26% over the last 23 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
Alert Aid 200 mg 46122-0457-73 Amerisource 16 tablets $0.085 Availability likely
Caffeine 200 mgthis 70000-0409-01 LEADER/ 16 tablets $0.085 Availability likely
Stay Awake 200 mg 70677-1126-01 Strategic 16 tablets $0.085 Availability likely
Stay Awake 200 mg 83324-0074-16 Chain 16 tablets $0.085 Availability likely
Awake Maximum Strength 200 mg 00363-3440-11 Walgreen 60 tablets FDA listed
Caffeine 200 mg 00363-5009-01 Walgreen 100 tablets FDA listed
stay awake 200 mg 11822-2260-02 Rite 100 tablets FDA listed
JET ALERT Double Strength 200 mg 15579-0200-16 Bell 90 tablets FDA listed
Stay Awake Maximum Strength 200 mg 21130-0226-10 Better 40 tablets FDA listed
Awake Maximum Strength 200 mg 21130-0944-11 Better 60 tablets FDA listed
Stay Awake 200 mg 30142-0284-40 KROGER 40 tablets FDA listed
Stay Awake 200 mg 30142-0726-10 Kroger 40 tablets FDA listed
Awake Maximum Strength 200 mg 36800-0844-11 Topco 60 tablets FDA listed
Stay Awake 200 mg 41163-0226-10 United 40 tablets FDA listed
Stay Awake Maximum Strength 200 mg 41163-0434-11 United 60 tablets FDA listed
Stay Awake 200 mg 49035-0226-31 Wal-Mart 80 tablets FDA listed
Alert 200 mg 49483-0343-44 Time 40 tablets FDA listed
Stay Awake 200 mg 50804-0262-10 Geiss, 40 tablets FDA listed
Alert Alertness Aid 200 mg 50844-0226-12 L.N.K. 100 tablets FDA listed
Stay Awake 200 mg 53943-0320-02 DISCOUNT 40 tablets FDA listed
Stay Awake 200 mg 55301-0226-10 ARMY 40 tablets FDA listed
Alert 200 mg 55910-0226-21 DOLGENCORP, 16 tablets FDA listed
stay awake 200 mg 56062-0030-01 PUBLIX 16 tablets FDA listed
Stay Awake 200 mg 57243-0226-21 Salado 16 tablets FDA listed
Stay Awake 200 mg 57344-0220-02 AAA 40 tablets FDA listed
caffeine 200 mg 58602-0747-47 Aurohealth 40 tablets FDA listed
Stay Awake 200 mg 63868-0114-16 CHAIN 16 tablets FDA listed
Stay Awake 200 mg 63941-0020-01 VALU 16 tablets FDA listed
NoDoz Alertness Aid 200 mg 66715-9899-03 Lil' 2 tablets FDA listed
Stay Awake 200 mg 67091-0117-16 WinCo 16 tablets FDA listed
Vivarin 200 mg 67751-0226-04 Navajo 4 tablets FDA listed
Alertness Aid 200 mg 68016-0680-16 Chain 16 tablets Discontinued
Stay Awake 200 mg 68998-0076-84 Marc 8 tablets FDA listed
Stay Awake 200 mg 69168-0076-40 Allegiant 40 tablets FDA listed
Caffeine 200 mg 69842-0500-11 CVS 60 tablets FDA listed
Caffeine 200 mg 69842-0509-10 CVS 40 tablets FDA listed
Vivarin 200 mg 71179-0018-16 Vespyr 16 tablets FDA listed
Stay Awake 200 mg 72036-0020-02 Harris 40 tablets FDA listed
Stay Awake 200 mg 72476-0102-01 RETAIL 16 tablets FDA listed
Topcare Stay Awake Maximum Strength 200 mg 76162-0002-58 TopCo 8 tablets FDA listed
Stay Awake 200 mg 83059-0008-01 Shield 15 tablets Discontinued
Stay Awake 200 mg 83059-0097-03 Shield 30 tablets FDA listed
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2019
On the market since
Apr 2019
📍
2026
Currently FDA-listed
7 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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 70000-0409-01, 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 – 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
12
Units reimbursed last 4 qtrs
10
Gross reimbursed last 4 qtrs
$1.78
Avg / prescription
$0.15
Avg / unit
$0.1780
Latest quarter Q4 2025
0Rx
Medicaid pays / ea
$0.1780
gross reimbursed
vs
NADAC / ea
$0.0848
acquisition cost
=
Spread
+$0.0932
+110% 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 · 12 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: no data reported NE Missouri: no data reported MO Kentucky: 10 units · 0.2 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
0.20.2
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 0.2 /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
70000-0409-01 You're viewing this 2 BLISTER PACK in 1 CARTON (70000-0409-1) / 8 TABLET in 1 BLISTER PACK 2019-04-05 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 12 words

Uses helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

⏱️ Dosage and Administration 21 words

Directions ■ adults and children 12 years of age and over: take 1 tablet not more often than every 4 hours

⚠️ Warnings 113 words

Warnings Do not use ■as a substitute for sleep. This product is intended for occasional use only ■in children under 12 years of age When using this product limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur. 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 (1-800-222-1222) right away.

🆘 Overdosage 16 words

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

🧪 Active Ingredient 10 words

Drug Facts Active ingredient (in each tablet) Caffeine 200 mg

🧪 Inactive Ingredients 23 words

Inactive ingredients corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, dicalcium phosphate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silica

🎯 Purpose 3 words

Purpose Alertness aid

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.