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nitrofurantoin (monohydrate/macrocrystals) 25 mg; 75 mg Capsule, 100-count — NDC 65862-929-01 (Billing 65862-0929-01)

by Aurobindo Pharma Limited · 100 CAPSULE in 1 BOTTLE

This is a package of 100 capsules of nitrofurantoin (monohydrate/macrocrystals) 25 mg; 75 mg Capsule from Aurobindo Pharma Limited, marketed since Mar 2023 and currently FDA-listed; retail pharmacies pay about $0.2958 per capsule (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 65862-0929-01
🏷️ FDA NDC (as labeled) 65862-929-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.2958 NADAC Per package$29.58 / 100 capsules Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.9493/unit · Part D plans $0.6443/unit — full pricing hub ↓
Main listing for product 65862-929 · Also comes in: 2000 capsules 65862-929-22
On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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) 65862-929-01
Product NDC 65862-929
11-digit billing NDC 65862092901
NCPDP billing unit EA — each (per item)
SPL Set ID 4026fb3b-a6f5-4305-86cb-af6c3ad47fea
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-03-30
Dosage form CAPSULE
Substance NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE

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

GPI-14 16800050150120
GCN Seq No 016598
GCN 49001
HICL code 006322
Ingredient (HICL) Nitrofurantoin Monohyd/M-Cryst
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W2
Therapeutic class — intermediate (HIC2) Antibacterials
HIC3 code W2F
Therapeutic class — specific (HIC3) Nitrofuran Derivatives Antibacterial Agents
AHFS code 08:36.00.00
AHFS class Urinary Anti-Infectives
FDB label name NITROFURANTOIN MONO-MCR 100 MG
FDB brand name Nitrofurantoin Mono-Macro
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 016598
  • GCN: 49001
  • GPI-14 (Medi-Span): 16800050150120
  • HICL (First Databank): 006322
  • AHFS class code: 08:36.00.00
Why two NDCs? The FDA registers this code as 65862-929-01 — 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 → 65862-0929-01. 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.

Clinical

Label name NITROFURANTOIN MONO-MCR 100 MG Ingredient Nitrofurantoin Monohyd/M-Cryst
🧪 What is this product?

Nitrofurantoin is an oral prescription capsule containing a nitrofuran antibacterial agent. It is typically used to treat bacterial urinary tract infections by working against bacteria that cause conditions like cystitis and urethritis. The capsule comes in two strengths (25 mg and 75 mg) and is taken by mouth. Nitrofurantoin monohydrate is a formulation of the same active ingredient designed for better absorption and tolerability.

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 eaPer package
Retail pharmacies payNADAC · weekly $0.296 $29.58 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $0.9493 $94.93 / 100 capsules
Medicare drug plans payPart D · Q2 2026 $0.6443 $64.43 / 100 capsules
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.352 $0.296
▼ Down 16% 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
65862-0929-01 You're viewing this Main listing 100 CAPSULE in 1 BOTTLE $0.2958 / ea $29.58 2023-03-30 — Active
65862-0929-22 65862-929-22 2000 CAPSULE in 1 BAG — — — — Active

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

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 capsule in 1 bottle.
How does this package differ from NDC 65862-0929-22?
Both are nitrofurantoin (monohydrate/macrocrystals) 25 mg; 75 mg Capsule — the drug itself is identical. This page's package is the 100-count one, while NDC 65862-0929-22 is the 2000 capsules package.
What NDC number is used to bill for this package of nitrofurantoin (monohydrate/macrocrystals) 25 mg; 75 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
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 00185-0122-01 Sandoz 100 capsules $0.296 AB Availability likely —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 00904-7571-61 Major 100 capsules $0.296 AB Availability likely —
Nitrofurantoin 25 mg/1; 75 mg 13811-0719-10 Trigen 100 capsules $0.296 AB Availability likely —
Nitrofurantoin 100 mg 42571-0393-01 Micro 100 capsules $0.296 AB Availability likely —
Nitrofurantoin Monohydrate/ Macrocrystalline 25 mg/1; 75 mg 47781-0303-01 Alvogen 100 capsules $0.296 AB Availability likely —
NITROFURANTOIN (monohydrate/macrocrystals) 75 mg/1; 25 mg 59746-0762-01 Jubilant 100 capsules $0.296 AB Availability likely —
nitrofurantoin (monohydrate/macrocrystals) 25 mg/1; 75 mgthis 65862-0929-01 Aurobindo 100 capsules $0.296 — Availability likely —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 68001-0606-00 BluePoint 100 capsules $0.296 AB Availability likely —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 70756-0404-11 Lifestar 100 capsules $0.296 AB Availability likely —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 72603-0196-01 NorthStar 100 capsules $0.296 AB Availability likely —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 65162-0478-10 Amneal 100 capsules $0.518 — FDA listed +75%
NITROFURANTOIN (monohydrate/macrocrystals) 75 mg/1; 25 mg 00615-8531-10 NCS 10 capsules — AB FDA listed —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 42708-0178-28 QPharma, 28 capsules — AB FDA listed —
NITROFURANTOIN (monohydrate/macrocrystals) 75 mg/1; 25 mg 42708-0184-28 QPharma, 28 capsules — AB FDA listed —
Nitrofurantoin 75 mg/1; 25 mg 50090-6664-00 A-S 14 capsules — AB FDA listed —
Nitrofurantoin 75 mg/1; 25 mg 50090-6750-01 A-S 10 capsules — AB FDA listed —
Macrobid 25 mg/1; 75 mg 52427-0285-01 Almatica 100 capsules — AB FDA listed —
Nitrofurantoin Mono 75 mg/1; 25 mg 54348-0849-06 PharmPak, 6 capsules — AB FDA listed —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 60760-0194-14 St. 14 capsules — AB FDA listed —
Nitrofurantoin 25 mg/1; 75 mg 60760-0853-14 St. 14 capsules — AB FDA listed —
Nitrofurantoin Monohydrate Macrocrystalline 25 mg/1; 75 mg 61919-0021-02 Direct_Rx 2 capsules — AB FDA listed —
Nitrofurantoin Monohydrate/ Macrocrystalline 25 mg/1; 75 mg 63187-0263-10 Proficient 10 capsules — AB FDA listed —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 63187-0995-10 Proficient 10 capsules — AB FDA listed —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 63629-1748-00 Bryant 6 capsules — AB FDA listed —
Nitrofurantoin 25 mg/1; 75 mg 63629-2464-01 Bryant 100 capsules — AB FDA listed —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 67046-1198-03 Coupler 30 capsules — AB FDA listed —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 67046-1271-03 Coupler 30 capsules — AB FDA listed —
Nitrofurantoin 25 mg/1; 75 mg 67296-1442-01 Redpharm 10 capsules — AB Discontinued —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 67296-2105-01 Redpharm 14 capsules — AB FDA listed —
NITROFURANTOIN (monohydrate/macrocrystals) 75 mg/1; 25 mg 67296-2180-01 Redpharm 10 capsules — AB FDA listed —
Nitrofurantoin 75 mg/1; 25 mg 68071-3569-02 NuCare 20 capsules — AB FDA listed —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 68071-3593-02 NuCare 2 capsules — AB FDA listed —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 68071-4367-02 NuCare 20 capsules — AB FDA listed —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 68071-4428-02 NuCare 2 capsules — AB FDA listed —
Nitrofurantoin 25 mg/1; 75 mg 68788-8258-00 Preferred 10 capsules — AB FDA listed —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 68788-8571-00 Preferred 10 capsules — AB FDA listed —
Nitrofurantoin Monohydrate/ Macrocrystalline 25 mg/1; 75 mg 70518-0265-00 REMEDYREPACK 30 capsules — AB Discontinued —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 70518-1087-02 REMEDYREPACK 30 capsules — AB Discontinued —
Macrobid 25 mg/1; 75 mg 70518-2531-00 REMEDYREPACK 10 capsules — AB FDA listed —
Nitrofurantoin 25 mg/1; 75 mg 70518-3717-00 REMEDYREPACK 14 capsules — AB FDA listed —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 70518-4026-00 REMEDYREPACK 10 capsules — AB FDA listed —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 70518-4358-00 REMEDYREPACK 30 capsules — AB FDA listed —
Nitrofurantoin 25 mg/1; 75 mg 71205-0852-00 Proficient 100 capsules — AB FDA listed —
Nitrofurantoin 25 mg/1; 75 mg 71335-2255-01 Bryant 40 capsules — AB FDA listed —
Nitrofurantoin 25 mg/1; 75 mg 71335-2320-00 Bryant 6 capsules — AB FDA listed —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 71335-2377-00 Bryant 6 capsules — AB FDA listed —
Nitrofurantoin 25 mg/1; 75 mg 71335-2914-01 Bryant 100 capsules — AB FDA listed —
Nitrofurantoin 25 mg/1; 75 mg 72162-1262-01 Bryant 100 capsules — AB FDA listed —
Nitrofurantoin 25 mg/1; 75 mg 72162-2615-01 Bryant 100 capsules — AB FDA listed —
Nitrofurantoin 25 mg/1; 75 mg 72189-0179-10 Directrx 10 capsules — AB FDA listed —
Nitrofurantoin Monohydrate/Macrocrystal 75 mg/1; 25 mg 72189-0395-14 Direct_Rx 14 capsules — AB FDA listed —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 72789-0234-10 PD-Rx 10 capsules — AB FDA listed —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 72789-0242-06 PD-Rx 6 capsules — AB FDA listed —
Nitrofurantoin 25 mg/1; 75 mg 72789-0386-06 PD-Rx 6 capsules — AB FDA listed —
Nitrofurantoin 25 mg/1; 75 mg 72789-0387-10 PD-Rx 10 capsules — AB FDA listed —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 76420-0195-01 Asclemed 100 capsules — AB FDA listed —
NITROFURANTOIN (monohydrate/macrocrystals) 75 mg/1; 25 mg 76420-0884-00 Asclemed 1000 capsules — AB FDA listed —
Nitrofurantoin (Monohydrate/Macrocrystals) 25 mg/1; 75 mg 82619-0147-01 Creekwood 100 capsules — AB FDA listed —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 82804-0115-10 Proficient 10 capsules — AB FDA listed —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 82868-0012-10 Northwind 10 capsules — AB FDA listed —
NITROFURANTOIN (monohydrate/macrocrystals) 75 mg/1; 25 mg 82868-0065-10 Northwind 10 capsules — AB 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

🏛️
2023
On the market since
Mar 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

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

LabelerAurobindo Pharma Limited
Labeler code65862
First marketedMar 2023
Product typeDrug For Further Processing
Portfolio1,456 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.

Full FDA label FDA SPL

The complete FDA label for this product, 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. Prefer the government’s original formatting? View this label on DailyMed ↗

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 this package alone, 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
110.6K
Units reimbursed last 4 qtrs
1.4M
Gross reimbursed last 4 qtrs
$1.33M
Avg / prescription
$12.00
Avg / unit
$0.9493
Latest quarter Q1 2026
34.2KRx
Medicaid pays / ea
$0.9493
gross reimbursed
vs
NADAC / ea
$0.2958
acquisition cost
=
Spread
+$0.6535
+221% 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 ⓘ
49% FFS 51% MCO
Fee-for-service · 54,038 Rx Managed care · 56,548 Rx
State Medicaid map
Alaska: 294 units · 40.1 per 100k residents AK Maine: 17,560 units · 1,259 per 100k residents ME Washington: 12,370 units · 158 per 100k residents WA Idaho: 8,630 units · 439 per 100k residents ID Montana: 1,380 units · 122 per 100k residents MT North Dakota: no data reported ND Minnesota: 20,229 units · 353 per 100k residents MN Wisconsin: 33,173 units · 561 per 100k residents WI Michigan: 27,963 units · 279 per 100k residents MI New York: 64,272 units · 328 per 100k residents NY Vermont: 5,149 units · 796 per 100k residents VT New Hampshire: 1,564 units · 112 per 100k residents NH Oregon: 8,195 units · 194 per 100k residents OR Nevada: 20,848 units · 653 per 100k residents NV Wyoming: 2,034 units · 348 per 100k residents WY South Dakota: 296 units · 32.2 per 100k residents SD Iowa: 8,846 units · 276 per 100k residents IA Illinois: 84,202 units · 671 per 100k residents IL Indiana: 3,750 units · 54.6 per 100k residents IN Ohio: 31,547 units · 268 per 100k residents OH Pennsylvania: 2,729 units · 21.1 per 100k residents PA New Jersey: 21,178 units · 228 per 100k residents NJ Massachusetts: 6,786 units · 96.9 per 100k residents MA California: 302,338 units · 776 per 100k residents CA Utah: 13,786 units · 403 per 100k residents UT Colorado: 67,042 units · 1,141 per 100k residents CO Nebraska: 16,161 units · 817 per 100k residents NE Missouri: 26,074 units · 421 per 100k residents MO Kentucky: 60,412 units · 1,335 per 100k residents KY West Virginia: 23,822 units · 1,346 per 100k residents WV Virginia: 9,880 units · 113 per 100k residents VA Maryland: 20,961 units · 339 per 100k residents MD Connecticut: 12,591 units · 348 per 100k residents CT Rhode Island: 5,922 units · 541 per 100k residents RI Arizona: 66,357 units · 893 per 100k residents AZ New Mexico: 42,759 units · 2,023 per 100k residents NM Kansas: 4,889 units · 166 per 100k residents KS Arkansas: 5,375 units · 175 per 100k residents AR Tennessee: 64,166 units · 900 per 100k residents TN North Carolina: 50,623 units · 467 per 100k residents NC South Carolina: 4,395 units · 81.8 per 100k residents SC Delaware: 3,971 units · 385 per 100k residents DE Oklahoma: 15,061 units · 372 per 100k residents OK Louisiana: 71,368 units · 1,560 per 100k residents LA Mississippi: 14,781 units · 503 per 100k residents MS Alabama: 14,588 units · 286 per 100k residents AL Georgia: 3,453 units · 31.3 per 100k residents GA D.C.: 975 units · 144 per 100k residents DC Hawaii: 5,039 units · 351 per 100k residents HI Texas: 32,490 units · 107 per 100k residents TX Florida: 56,235 units · 249 per 100k residents FL
Units reimbursed · per 100k residents
21.12,023
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 Mexico 2,023 /100k
2 Louisiana 1,560 /100k
3 West Virginia 1,346 /100k
4 Kentucky 1,335 /100k
5 Maine 1,259 /100k
6 Colorado 1,141 /100k
7 Tennessee 900 /100k
8 Arizona 893 /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.
100 capsules this page65862-0929-01 110,586 Rx · $1,327,543
2000 capsules65862-0929-22 No Medicaid data
Drug total (last 4 qtrs): 110,586 Rx · 1,398,509 units · $1,327,543 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 Nitrofurantoin (monohydrate/macrocrystals) — the ingredient across all brands.

Top reported reactions

Urinary Tract Infection1,375
Fatigue1,281
Nausea1,244
Headache1,156
Dyspnoea1,013
Pain1,001
Diarrhoea916

Age at onset

Neonate51
Infant16
Child21
Adolescent18
Adult1,368
Elderly1,177

Reporter sex

16,612 reports
Male · 16%
Female · 84%
Unknown · 0%

Serious outcomes

Hospitalization5,709
Death1,041
Life-threatening873
Disabling850
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,522 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.

About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Aurobindo Pharma Limited supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

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 — Not published for this NDC No photo available yet for this listing.
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 — 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) ✓ Available
“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 "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
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.
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 Aurobindo Pharma Limited. 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 1 other package presentation of this same product, including 2000 capsules (65862-0929-22). 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?
Aurobindo Pharma Limited 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.
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.
← 65862-0928-36 · Aurobindo 65862-0930-90 · Aurobindo →
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.