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Aspirin 325 mg Tablet, 100-count — NDC 69168-0312-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Aspirin 325 mg Tablet, 100-count — NDC 69168-312-01 (Billing 69168-0312-01)

by Allegiant Health · 100 TABLET in 1 BOTTLE (69168-312-01)

NDC 69168-312-01 (billing 69168-0312-01) is a package of 100 tablets of Aspirin 325 mg Tablet from Allegiant Health, marketed since Dec 2014 and currently FDA-listed.

NDC 69168-0312-01
🏷️ FDA NDC (as labeled) 69168-312-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes5 compare ↓
Also comes in: 40 tablets 69168-312-40 120 tablets 69168-312-06 200 tablets 69168-312-98 300 tablets 69168-312-17
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69168-312-01
Product NDC 69168-312
11-digit billing NDC 69168031201
RxCUI 212033
UNII R16CO5Y76E
Application # M013
SPL Set ID 88b54062-8b3d-4024-a957-62b3255184b9
Established class (EPC) Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation Inhibitor
Mechanism of action Cyclooxygenase Inhibitors
Physiologic effect Decreased Prostaglandin Production; Decreased Platelet Aggregation
Chemical class Anti-Inflammatory Agents, Non-Steroidal
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-12-18
Route ORAL
Dosage form TABLET
Substance ASPIRIN
Quick answers for NDC 69168-312-01
  • RxCUI (RxNorm): 212033
  • 11-digit billing NDC: 69168031201
Why two NDCs? The FDA registers this code as 69168-312-01 — 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 → 69168-0312-01. 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 Platelet Aggregation Inhibitor class.

Pharmacologic class Platelet Aggregation Inhibitor, Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other agents for local oral treatment, Platelet aggregation inhibitors excl. heparin, Salicylic acid and derivatives
How it works Cyclooxygenase Inhibitors
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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Aspirin is used to temporarily relieve common minor pains — things like headaches, backaches, muscle aches, toothaches, menstrual cramps, and discomfort from a cold — and to reduce...
  • Generally, no — aspirin should not be given to children under 12. More importantly, children and teenagers who have or are recovering from chickenpox or a flu-like illness should n...
  • Yes, stomach upset, heartburn, and nausea are real possibilities with aspirin. Taking it with a full glass of water helps. Some people tolerate enteric-coated or delayed-release fo...
  • Does aspirin upset your stomach? What can I do about it?
📖 Read our full Aspirin 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.

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 eachPer 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.
Try another pack size: 40 tablets 120 tablets 200 tablets 300 tablets
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69168-0312-01 69168-312-01 You're viewing this 100 TABLET in 1 BOTTLE (69168-312-01) 2014-12-18 Active
69168-0312-17 69168-312-17 300 TABLET in 1 BOTTLE (69168-312-17) 2014-12-18 Active
69168-0312-06 69168-312-06 120 TABLET in 1 BOTTLE (69168-312-06) 2023-11-06 Active
69168-0312-40 69168-312-40 40 TABLET in 1 BOTTLE (69168-312-40) 2023-08-23 Active
69168-0312-98 69168-312-98 200 TABLET in 1 BOTTLE (69168-312-98) 2023-08-23 Active

You're viewing one of 5 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 69168-0312-01?
NDC 69168-0312-01 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 69168-0312-01 and NDC 69168-0312-40?
Both are Aspirin 325 mg Tablet — the drug itself is identical. NDC 69168-0312-01 is the 100-count package, while NDC 69168-0312-40 is the 40 tablets package.
What NDC number is used to bill for this package of Aspirin 325 mg Tablet?
Bill NDC 69168-0312-01 — the 11-digit billing format is 69168031201. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Aspirin 325 mg 00536-1054-05 Rugby 500 tablets $0.011 — Discontinued —
Aspirin 325 mg 63868-0352-03 CHAIN 300 tablets $0.011 — Discontinued —
Aspirin 325 mg 46122-0691-78 Amerisource 100 tablets $0.017 — Availability likely —
McKesson Aspirin 325 mg 68599-1311-03 McKesson 2 tablets $0.017 — Availability likely —
Aspirin 325 mg 70000-0253-02 Cardinal 100 tablets $0.017 — Availability likely —
Aspirin 325 mg 70677-1189-01 Strategic 100 tablets $0.017 — Availability likely —
Aspirin 325 mg 83324-0066-01 Chain 100 tablets $0.017 — Availability likely —
Aspirin 325 mg 83324-0205-01 CHAIN 100 tablets $0.017 — Availability likely —
Tri-Buffered Aspirin 325 mg 00904-2015-59 Major 100 tablets $0.021 — Discontinued —
Buffered Aspirin 325 mg 70000-0147-01 Cardinal 130 tablets $0.021 — Availability likely —
Bayer Genuine Aspirin 325 mg 00280-2000-01 Bayer 300 tablets — — FDA listed —
Aspirin Regular Strength 325 mg 00363-0157-14 Walgreen 500 tablets — — FDA listed —
Physicians Care Aspirin 325 mg 00924-0105-00 Acme 2 tablets — — FDA listed —
Bayer Genuine Aspirin 325 mg 00924-6020-02 Acme 100 tablets — — FDA listed —
Regular strength aspirin 325 mg 11673-0188-53 TARGET 500 tablets — — FDA listed —
Pain Relief Aspirin 325 mg 11822-0157-02 Rite 100 tablets — — FDA listed —
Aspirin 325 mg 17714-0010-01 Advance 100 tablets — — FDA listed —
Aspirin 325 mg 21130-0758-53 BETTER 500 tablets — — FDA listed —
Aspirin 325 mg 21130-0957-14 Better 500 tablets — — Discontinued —
Aspirin 325 mg 36800-0157-12 Topco 100 tablets — — FDA listed —
Aspirin 325 mg 37808-0157-12 H 100 tablets — — Discontinued —
Aspirin 325 mg 37835-0577-01 Bi-Mart 100 tablets — — FDA listed —
Aspirin 325 mg 37835-0738-02 Bi-Mart 100 tablets — — FDA listed —
Aspirin 325 mg 41163-0157-12 United 100 tablets — — FDA listed —
Regular Strength Aspirin 325 mg 41226-0011-32 Kroger 300 tablets — — FDA listed —
Aspirin Regular Strength 325 mg 41250-0118-11 Meijer 100 tablets — — Discontinued —
Aspirin Regular Strength 325 mg 41520-0157-78 FOODHOLD 100 tablets — — FDA listed —
ASPIRIN 325 mg 42507-0018-11 HYVEE 100 tablets — — FDA listed —
Bayer Genuine Aspirin 325 mg 47682-0456-47 Unifirst 2 tablets — — FDA listed —
Medique at Home Aspirin 325 mg 47682-0533-33 Unifirst 2 tablets — — FDA listed —
Medique Products Aspirin 325 mg 47682-0616-13 Unifirst 2 tablets — — FDA listed —
Medi-First Aspirin 325 mg 47682-0617-13 Unifirst 2 tablets — — FDA listed —
Medi-First Plus Aspirin 325 mg 47682-0618-33 Unifirst 2 tablets — — FDA listed —
Aspirin 325 mg 49035-0157-06 Wal-Mart 200 tablets — — Discontinued —
Unishield Aspirin 325 mg 49314-1163-03 Unishield 2 tablets — — FDA listed —
Aspirin 325 mg 49483-0011-00 TIME 100000 tablets — — FDA listed —
Bufferin Regular Strength Pain Relief 325 mg 50066-0610-13 Genomma 130 tablets — — FDA listed —
Aspirin 325 mg 50090-6195-08 A-S 100 tablets — — FDA listed —
Bayer Genuine Aspirin 325 mg 50269-0005-06 JC 24 tablets — — FDA listed —
Bayer Genuine Aspirin 325 mg 50269-0006-06 JC 12 tablets — — FDA listed —
Aspirin 325 mg 50332-0139-03 HART 50 tablets — — FDA listed —
Aspirin 325 mg 50804-0157-12 Geiss, 100 tablets — — FDA listed —
Aspirin 325 mg 50844-0157-12 L.N.K. 100 tablets — — FDA listed —
Coated Aspirin 325 mg 50844-0254-12 L.N.K. 100 tablets — — FDA listed —
Aspirn 325 mg 51662-1583-01 HF 2 tablets — — FDA listed —
Aspirin 325 mg 53185-0249-12 Athlete's 100 tablets — — FDA listed —
Aspirin 325 mg 53943-0157-12 Discount 100 tablets — — FDA listed —
Geritrex Aspirin 325 mg 54162-0940-90 Geritrex 1000 tablets — — FDA listed —
Aspirin 325 mg 54738-0541-01 Richmond 100 tablets — — FDA listed —
Aspirin 325 mg 55301-0157-12 ARMY 100 tablets — — FDA listed —
Rapidol Aspirin 325 mg 55758-0363-60 Pharmadel 60 tablets — — FDA listed —
Aspirin 325 mg 55910-0249-29 DOLGENCORP, 150 tablets — — FDA listed —
aspirin 325 mg 56062-0118-11 PUBLIX 100 tablets — — FDA listed —
Aspirin 325 mg 57243-0157-12 Salado 100 tablets — — FDA listed —
Aspirin 325 mg 57344-0018-11 AAA 100 tablets — — FDA listed —
Aspirin 325 mg 57896-0901-01 Geri-Care 100 tablets — — FDA listed —
Aspirin 325 mg 58228-0071-01 PROSTAT 20000 tablets — — FDA listed —
Travel Savvy Aspirin 325 mg 59961-0616-15 Bellegrove 2 tablets — — FDA listed —
Aspirin 325 mg 60760-0930-24 St. 24 tablets — — FDA listed —
Direct Safety Aspirin 325 mg 61245-0616-13 Direct 2 tablets — — FDA listed —
Aspirin 325 mg 63941-0118-19 VALU 300 tablets — — FDA listed —
Aspirin NSAID 325 mg 63941-0157-12 Valu 100 tablets — — FDA listed —
Aspirin 325 mg 63941-0249-12 Valu 100 tablets — — Discontinued —
Circle K Aspirin 325 325 mg 66715-5504-04 Lil 100 tablets — — FDA listed —
BAYER Aspirin Original, TRAVEL BASIX 325 mg 66715-6426-02 Lil' 4 tablets — — FDA listed —
BAYER Aspirin Original, CVP HEALTH 325 mg 66715-6526-02 Lil' 4 tablets — — FDA listed —
Lil Drug Store Aspirin 325 325 mg 66715-6840-06 Lil 100 tablets — — FDA listed —
Bayer 325 mg 66715-9726-02 Lil' 4 tablets — — FDA listed —
Bayer Genuine Aspirin 325 mg 67751-0129-01 Navajo 2 tablets — — FDA listed —
Aspirin 325 mg 68788-8256-01 Preferred 100 tablets — — FDA listed —
Aspirin 325 mg 68998-0018-11 Marc 100 tablets — — FDA listed —
Aspirin 325 mgthis 69168-0312-01 Allegiant 100 tablets — — FDA listed —
Aspirin 325 mg 69396-0158-01 Trifecta 100 tablets — — FDA listed —
Aspirin 325 mg 69396-0173-01 Trifecta 1000 tablets — — FDA listed —
Extra Strength Aspirin 325 mg 69517-0002-05 HealthLife 500 tablets — — Discontinued —
Aspirin 325 mg 69732-0008-01 Hi-Tech 200 tablets — — FDA listed —
ULINE Aspirin 325 mg 69790-0616-33 ULINE 2 tablets — — FDA listed —
Bayer Genuine Aspirin 325 mg 70264-0013-01 R 100 tablets — — FDA listed —
Aspirin Packs 325 mg 70385-2006-02 Sina 2 tablets — — FDA listed —
Tri-Buffered Aspirin 325 mg 71205-0517-30 Proficient 30 tablets — — FDA listed —
Aspirin 325 mg 71679-0302-00 Health 28500 tablets — — FDA listed —
Aspirin 325 mg 72036-0018-11 HARRIS 100 tablets — — FDA listed —
Aspirin Regular Strength 325 mg 72476-0018-11 RETAIL 100 tablets — — FDA listed —
Aspirin 325 mg 72789-0574-25 PD-Rx 25 tablets — — FDA listed —
Aspirin Regular Strength 325 mg 73057-0365-08 Ulai 100 tablets — — FDA listed —
Thompson Aspirin 325 mg 73408-0618-33 Thompson 2 tablets — — FDA listed —
Aspirin 50 CT 325 mg 73598-1112-01 JHK 50 tablets — — FDA listed —
Aspirin 325 mg 77333-0050-20 Gendose 1 tablet — — FDA listed —
Aspirin 325 mg 79481-1570-01 Meijer 100 tablets — — FDA listed —
Aspirin 325 mg 82804-0167-60 Proficient 60 tablets — — FDA listed —
Aspirin 325 mg 82804-0237-04 Proficient 4 tablets — — FDA listed —
Extra Strength Aspirin 325 mg 83586-0115-01 HHH 100 tablets — — FDA listed —
Aspirin 325 mg 85111-0901-10 RMT 1000 tablets — — FDA listed —
Bayer Genuine Aspirin 325 mg 85237-1828-01 Select 1 tablet — — FDA listed —
Medique at Home Aspirin 325 mg 85766-0125-01 Sportpharm 2 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

🏛️
2014
On the market since
Dec 2014
📍
2026
Currently FDA-listed
12 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.

What it looks like

Color white
ShapeRound
ImprintASPIRIN
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.

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.

Manufacturer & labeler

LabelerAllegiant Health
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code69168
First marketedDec 2014
Product typeHuman Otc Drug
Portfolio113 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.

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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 18 words ▾

Uses temporarily relieves: headache pain and fever of colds toothache menstrual pain muscle pain minor pain of arthritis

⏱️ Dosage and Administration 62 words ▾

Directions do not take more than directed drink a full glass of water with each dose adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours not to exceed 12 tablets in 24 hours unless directed by a doctor children under 12 years: do not use unless directed by a doctor

⚠️ Warnings ~2 min read ▾

Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction, which may include: facial swelling shock hives asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if you are age 60 or older take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have had stomach ulcers or bleeding problems have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you are allergic to aspirin or any other pain reliever/fever reducer if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have asthma stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you are taking a diuretic you have high blood pressure, heart disease, liver cirrhosis, or kidney disease Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis Stop use and ask a doctor if an allergic reaction occurs.

Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better ringing in the ears or a loss of hearing occurs pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition. If pregnant or breast-feeding ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

🧪 Active Ingredient 9 words ▾

Active ingredient Aspirin 325 mg (NSAID*) *nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 4 words ▾

Inactive Ingredients corn starch

🎯 Purpose 3 words ▾

Purpose Pain reliever

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

About this NDC listing & data coverage

Over-the-counter (OTC) 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
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 69168-312-01, 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: 69168-0312-01, written without dashes as 69168031201. 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 69168-0312-01, the first segment (69168) is the labeler code FDA assigned to Allegiant Health; the middle segment (0312) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Allegiant Health. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 40 tablets (69168-0312-40), 120 tablets (69168-0312-06), 200 tablets (69168-0312-98). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Allegiant Health 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.
← 69168-0309-08 · Allegiant 69168-0318-06 · Allegiant →
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.