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in the FDA label

Cefdinir 300 mg Capsule, 60-count — NDC 16714-391-02 (Billing 16714-0391-02)

by NorthStar Rx LLC · 60 CAPSULE in 1 BOTTLE

This is a package of 60 capsules of Cefdinir 300 mg Capsule from NorthStar Rx LLC, no longer marketed, no longer in the FDA NDC Directory; retail pharmacies pay about $0.4413 per capsule (NADAC).

NDC 16714-0391-02
🏷️ FDA NDC (as labeled) 16714-391-02 billing pads the product segment with a zero
This package
Contains60-count Cost per ea$0.4413 NADAC Per package$26.48 / 60 capsules Pack sizes2 compare ↓
Product page 16714-0391-01 Also comes in: 30 capsules 16714-391-01
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Mar 13, 2024 · 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

NDC database record

One package, one record: these facts belong to NDC 16714-391-02 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
16714 labeler · 391 product · 02 package
Billing quantity
60 EA per package
Barcode (UPC-A, from the NDC)
3 1671439102 1
FDA record last changed
Mar 13, 2024
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Oct 2023. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 16714-391-02
Product NDC 16714-391
11-digit billing NDC 16714039102
NCPDP billing unit EA — each (per item)
Application # ANDA065434
Chemical class Cephalosporin Antibacterial [EPC], Cephalosporins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Oct 2023)
Route ORAL
Dosage form CAPSULE
Substance CEFDINIR
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 040257
GCN 32231
HICL code 018548
Ingredient (HICL) Cefdinir
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1Y
Therapeutic class — specific (HIC3) Cephalosporin Antibiotics - 3Rd Generation
AHFS code 08:12.06.12
AHFS class 3Rd Generation Cephalosporin Antibiotics
FDB label name CEFDINIR 300 MG CAPSULE
FDB brand name Cefdinir
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 040257
  • GCN: 32231
  • HICL (First Databank): 018548
  • AHFS class code: 08:12.06.12
Why two NDCs? The FDA registers this code as 16714-391-02 — 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 → 16714-0391-02. 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.

Clinical

Label name CEFDINIR 300 MG CAPSULE Ingredient Cefdinir
📖 What it is MedlinePlus · NLM

Cefdinir is used to treat certain infections caused by bacteria. Cefdinir is in a class of medications called cephalosporin antibiotics. It works by killing bacteria. Antibiotics such as cefdinir will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats mild to moderate bacterial infections such as pneumonia, sinus infections, strep throat, skin infections and, in children, ear infections. It will not help colds or the f...
  • No. You can take it with or without food. Try to take it at about the same times each day, and finish the full course even if you feel better.
  • It can be. Aluminum or magnesium antacids and iron supplements can lower how much cefdinir your body absorbs. Take cefdinir at least 2 hours before or after them.
  • I take an antacid or iron. Is that a problem?
📖 Read our full Cefdinir guide →
7
Nutrient depletion considerations

Cefdinir may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Cefdinir nutrient depletion report →
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.

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 $0.441 $26.48 / 60 capsules
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.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Mar 2022 Jul 2022 Nov 2022 $0.464 $0.441
▼ Down 2% over the last 12 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
16714-0391-01 16714-391-01 Main listing 30 CAPSULE in 1 BOTTLE $0.4413 / ea $13.24 2008-01-07 — Discontinued by firm
16714-0391-02 You're viewing this 60 CAPSULE in 1 BOTTLE $0.4413 / ea $26.48 2008-01-07 — Discontinued by firm

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

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.4413 NADAC).

Pack size FAQ

What quantity is in this package?
This is a 60-count package — 60 capsule in 1 bottle.
How does this package differ from NDC 16714-0391-01?
Both are Cefdinir 300 mg Capsule — the drug itself is identical. This page's package is the 60-count one, while NDC 16714-0391-01 is the 30 capsules package.
What NDC number is used to bill for this package of Cefdinir 300 mg Capsule?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cefdinir 300 mgthis 16714-0391-02 NorthStar 60 capsules $0.441 AB Discontinued —
Cefdinir 300 mg 00093-3160-06 Teva 60 capsules $0.458 AB Availability likely +4%
Cefdinir 300 mg 00904-7563-04 Major 30 capsules $0.458 AB Availability likely +4%
Cefdinir 300 mg 57237-0099-60 Rising 60 capsules $0.458 AB Availability likely +4%
Cefdinir 300 mg 60687-0699-21 American 30 capsules $0.458 AB Availability likely +4%
Cefdinir 300 mg 68001-0362-06 BluePoint 60 capsules $0.458 AB Availability likely +4%
Cefdinir 300 mg 68180-0711-60 Lupin 60 capsules $0.458 AB Availability likely +4%
Cefdinir 300 mg 00781-2176-01 Sandoz 100 capsules — AB FDA listed —
Cefdinir 300 mg 42291-0043-60 AvKARE 60 capsules — AB FDA listed —
Cefdinir 300 mg 43063-0959-20 PD-Rx 20 capsules — AB FDA listed —
Cefdinir 300 mg 43063-0964-14 PD-Rx 14 capsules — AB FDA listed —
Cefdinir 300 mg 50090-1033-00 A-S 10 capsules — AB FDA listed —
Cefdinir 300 mg 50090-2719-00 A-S 10 capsules — AB FDA listed —
Cefdinir 300 mg 50090-6041-00 A-S 10 capsules — AB FDA listed —
Cefdinir 300 mg 50090-6042-00 A-S 20 capsules — AB FDA listed —
Cefdinir 300 mg 63187-0989-14 Proficient 14 capsules — AB FDA listed —
Cefdinir 300 mg 63629-5101-01 Bryant 10 capsules — AB FDA listed —
Cefdinir 300 mg 63629-8968-01 Bryant 20 capsules — AB FDA listed —
cefdinir 300 mg 65862-0177-05 Aurobindo 500 capsules — — FDA listed —
Cefdinir 300 mg 67296-1448-07 Redpharm 14 capsules — AB Discontinued —
Cefdinir 300 mg 67877-0543-01 Ascend 100 capsules — AB FDA listed —
Cefdinir 300 mg 68071-2401-02 NuCare 2 capsules — AB FDA listed —
Cefdinir 300 mg 68071-2503-02 NuCare 20 capsules — AB FDA listed —
Cefdinir 300 mg 68071-3998-02 NuCare 2 capsules — AB FDA listed —
Cefdinir 300 mg 68071-4007-02 NuCare 20 capsules — AB FDA listed —
Cefdinir 300 mg 68071-4856-02 NuCare 20 capsules — AB FDA listed —
Cefdinir 300 mg 68071-4946-02 NuCare 2 capsules — AB FDA listed —
Cefdinir 300 mg 68071-5145-02 NuCare 20 capsules — AB FDA listed —
Cefdinir 300 mg 68788-7339-02 Preferred 20 capsules — AB FDA listed —
Cefdinir 300 mg 68788-7987-02 Preferred 20 capsules — AB FDA listed —
Cefdinir 300 mg 68788-8323-02 Preferred 20 capsules — AB FDA listed —
Cefdinir 300 mg 68788-8404-02 Preferred 20 capsules — AB FDA listed —
Cefdinir 300 mg 70518-1880-00 REMEDYREPACK 20 capsules — AB FDA listed —
Cefdinir 300 mg 70518-4169-00 REMEDYREPACK 20 capsules — AB FDA listed —
Cefdinir 300 mg 71205-0224-14 Proficient 14 capsules — AB FDA listed —
Cefdinir 300 mg 71205-0576-06 Proficient 6 capsules — AB FDA listed —
Cefdinir 300 mg 72189-0308-14 DirectRx 14 capsules — AB FDA listed —
Cefdinir 300 mg 72189-0423-14 Direct_Rx 14 capsules — AB FDA listed —
Cefdinir 300 mg 72789-0054-14 PD-Rx 14 capsules — AB FDA listed —
Cefdinir 300 mg 72789-0061-20 PD-Rx 20 capsules — AB FDA listed —
Cefdinir 300 mg 72789-0550-10 PD-Rx 10 capsules — AB FDA listed —
Cefdinir 300 mg 82868-0059-20 Northwind 20 capsules — 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

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

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.

🧪 Avoiding an ingredient? See Cefdinir inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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

LabelerNorthStar Rx LLC
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA065434 (ANDA)
Labeler code16714
Product typeHuman Prescription Drug
Portfolio415 products on file

More NDCs from NorthStar Rx LLC labeler code 16714

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.

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.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.

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

Medicare Part D (outpatient prescription) spending for Cefdinir — the program that covers self-administered drugs. 8 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 Cefdinir. 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
$8.13M
Claims incl. refills
582.9K
Beneficiaries
534.9K
Spend / beneficiary
$15.20
Spend / claim
$13.95
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.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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) — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA.
Package photos — Not published for this NDC The FDA label for this product carries no photos.
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) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
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

Why is there no full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 30 capsules (16714-0391-01). 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?
NorthStar Rx LLC 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 16714-0390-01 · NorthStar 16714-0394-01 · NorthStar →
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.