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Lisinopril and hydrochlorothiazide 20 mg; 12.5 mg Tablet, 100-count — NDC 00591-0861-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Lisinopril and hydrochlorothiazide 20 mg; 12.5 mg Tablet, 100-count — NDC 0591-0861-01 (Billing 00591-0861-01)

by Actavis Pharma, Inc. · 100 TABLET in 1 BOTTLE, PLASTIC

This is a package of 100 tablets of Lisinopril and hydrochlorothiazide 20 mg; 12.5 mg Tablet from Actavis Pharma, Inc., marketed since Mar 2003 and currently FDA-listed; retail pharmacies pay about $0.0361 per tablet (NADAC). It is the main listing for this product, which comes in 3 package sizes.

NDC 00591-0861-01
🏷️ FDA NDC (as labeled) 0591-0861-01 billing pads the labeler segment with a zero
This package
Contains100-count Cost per ea$0.0361 NADAC Per package$3.61 / 100 tablets Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.1674/unit · Part D plans $0.1025/unit — full pricing hub ↓
Main listing for product 0591-0861 · Also comes in: 500 tablets 0591-0861-05 25000 tablets 0591-0861-00
On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 0591-0861-01 alone.

Record
FDA NDC Directory package listing · Drug for further processing
Code segments
0591 labeler · 0861 product · 01 package
Listing certified through
Dec 31, 2026
Billing quantity
100 EA per package
Barcode (UPC-A, from the NDC)
3 0591086101 8
Medicaid fills, this package
580 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026
⚠️
Other active recalls for Lisinopril And Hydrochlorothiazide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 20, 2025 — Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg. (Lupin Pharmaceuticals Inc.) · FDA recall D-0532-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0591-0861-01
Product NDC 0591-0861
11-digit billing NDC 00591086101
NCPDP billing unit EA — each (per item)
SPL Set ID 6ec7d3cd-452d-42e0-ac10-8730bb3f0ba6
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2003-03-01
Dosage form TABLET
Substance LISINOPRIL; HYDROCHLOROTHIAZIDE

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

GPI-14 36991802550310
GPI class Lisinopril-hydroCHLOROthiazide
GCN Seq No 000388
GCN 88000
HICL code 000131
Ingredient (HICL) Lisinopril/Hydrochlorothiazide
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A4
Therapeutic class — intermediate (HIC2) Antihypertensives
HIC3 code A4J
Therapeutic class — specific (HIC3) Ace Inhibitor-Thiazide Or Thiazide-Like Diuretic
AHFS code 24:32.04.00
AHFS class Angiotensin-Converting Enzyme Inhibitors
FDB label name LISINOPRIL-HCTZ 20-12.5 MG TAB
FDB brand name Lisinopril-Hydrochlorothiazide
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 000388
  • GCN: 88000
  • GPI-14 (Medi-Span): 36991802550310
  • HICL (First Databank): 000131
  • AHFS class code: 24:32.04.00
Why two NDCs? The FDA registers this code as 0591-0861-01 — a 4-4-2 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 labeler segment → 00591-0861-01. 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 LISINOPRIL-HCTZ 20-12.5 MG TAB Ingredient Lisinopril/Hydrochlorothiazide
📗 Our plain-language guide HelloPharmacist
  • Great question. Lisinopril relaxes your blood vessels by blocking a chemical that causes them to tighten. Hydrochlorothiazide helps your kidneys remove extra salt and fluid. Togeth...
  • What exactly is this medication doing for me — why do I need two drugs in one pill?
  • Yes, that cough is a known side effect of the lisinopril part of this combination. It's not dangerous, but it can be really annoying. Don't just stop the medication on your own — t...
  • I've noticed a dry, nagging cough since I started this. Is that from the medication?
📖 Read our full Lisinopril and Hydrochlorothiazide 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 eaPer package
Retail pharmacies payNADAC · weekly $0.036 $3.61 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.1674 $16.74 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.1025 $10.25 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.052 $0.036
▼ Down 30% over the last 24 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
00591-0861-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE, PLASTIC $0.0361 / ea $3.61 2003-03-04 — Active
00591-0861-05 0591-0861-05 500 TABLET in 1 BOTTLE, PLASTIC $0.0361 / ea $18.06 2003-03-04 — Active
00591-0861-00 0591-0861-00 25000 TABLET in 1 BAG — — — — Active

You're viewing the smallest of 3 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0361 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 57% 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 tablet in 1 bottle, plastic.
How does this package differ from NDC 00591-0861-05?
Both are Lisinopril and hydrochlorothiazide 20 mg; 12.5 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 00591-0861-05 is the 500 tablets package.
What NDC number is used to bill for this package of Lisinopril and hydrochlorothiazide 20 mg; 12.5 mg Tablet?
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
Lisinopril and hydrochlorothiazide 20 mg/1; 12.5 mgthis 00591-0861-01 Actavis 100 tablets $0.036 — Availability likely —
Lisinopril and Hydrochlorothiazide 20 mg/1; 12.5 mg 43547-0421-10 Solco 100 tablets $0.036 AB Availability likely —
Lisinopril and Hydrochlorothiazide 12.5 mg/1; 20 mg 68180-0519-01 Lupin 100 tablets $0.036 AB Availability likely —
Lisinopril and Hydrochlorothiazide 12.5 mg/1; 20 mg 68645-0557-54 Legacy 30 tablets $0.036 AB Availability likely —
Lisinopril and Hydrochlorothiazide 20 mg/1; 12.5 mg 76282-0447-01 Exelan 100 tablets $0.036 AB Availability likely —
Lisinopril and Hydrochlorothiazide 12.5 mg/1; 20 mg 43063-0458-30 PD-Rx 30 tablets — AB FDA listed —
Lisinopril and Hydrochlorothiazide 20 mg/1; 12.5 mg 50090-6204-00 A-S 30 tablets — AB FDA listed —
Lisinopril and Hydrochlorothiazide 20 mg/1; 12.5 mg 50090-6752-00 A-S 90 tablets — AB FDA listed —
LISINOPRIL and HYDROCHLOROTHIAZIDE 20 mg/1; 12.5 mg 51407-0565-05 GSMS, 500 tablets — AB FDA listed —
Lisinopril and Hydrochlorothiazide 12.5 mg/1; 20 mg 51655-0311-26 Northwind 90 tablets — AB FDA listed —
Lisinopril and Hydrochlorothiazide 20 mg/1; 12.5 mg 51655-0414-26 Northwind 90 tablets — AB FDA listed —
Zestoretic 20 mg/1; 12.5 mg 52427-0436-90 Almatica 90 tablets — AB FDA listed —
Lisinopril and Hydrochlorothiazide 20 mg/1; 12.5 mg 60760-0519-90 St. 90 tablets — AB FDA listed —
Lisinopril and hydrochlorothiazide 20 mg/1; 12.5 mg 63187-0050-00 Proficient 100 tablets — AB FDA listed —
Lisinopril and Hydrochlorothiazide 12.5 mg/1; 20 mg 63629-4470-01 Bryant 30 tablets — AB FDA listed —
Lisinopril and Hydrochlorothiazide 20 mg/1; 12.5 mg 65862-0044-00 Aurobindo 100 tablets — — FDA listed —
Lisinopril and Hydrochlorothiazide 12.5 mg/1; 20 mg 67046-0433-03 Coupler 30 tablets — AB FDA listed —
Lisinopril and Hydrochlorothiazide 20 mg/1; 12.5 mg 68071-2263-09 NuCare 90 tablets — AB FDA listed —
Lisinopril and Hydrochlorothiazide 12.5 mg/1; 20 mg 68071-3177-03 NuCare 30 tablets — AB FDA listed —
Lisinopril and Hydrochlorothiazide 20 mg/1; 12.5 mg 68071-4435-03 NuCare 30 tablets — AB FDA listed —
Lisinopril and Hydrochlorothiazide 20 mg/1; 12.5 mg 68788-8253-01 Preferred 100 tablets — AB FDA listed —
Lisinopril And Hydrochlorothiazide 12.5 mg/1; 20 mg 68788-9809-01 Preferred 100 tablets — AB FDA listed —
Lisinopril and Hydrochlorothiazide 20 mg/1; 12.5 mg 69097-0969-05 Cipla 90 tablets — AB FDA listed —
Lisinopril and Hydrochlorothiazide 12.5 mg/1; 20 mg 70518-0382-00 REMEDYREPACK 90 tablets — AB Discontinued —
Lisinopril and Hydrochlorothiazide 20 mg/1; 12.5 mg 70518-3505-00 REMEDYREPACK 90 tablets — AB FDA listed —
Lisinopril and Hydrochlorothiazide 12.5 mg/1; 20 mg 71205-0022-00 Proficient 100 tablets — AB FDA listed —
Lisinopril and Hydrochlorothiazide 20 mg/1; 12.5 mg 71205-0763-30 Proficient 30 tablets — AB FDA listed —
Lisinopril and Hydrochlorothiazide 20 mg/1; 12.5 mg 71335-0862-01 Bryant 30 tablets — AB Discontinued —
Lisinopril and Hydrochlorothiazide 20 mg/1; 12.5 mg 71335-9730-01 Bryant 30 tablets — AB FDA listed —
Lisinopril and Hydrochlorothiazide 20 mg/1; 12.5 mg 71610-0274-80 Aphena 180 tablets — AB FDA listed —
Lisinopril and Hydrochlorothiazide 20 mg/1; 12.5 mg 71610-0374-60 Aphena 90 tablets — AB FDA listed —
Lisinopril and Hydrochlorothiazide 12.5 mg/1; 20 mg 71610-0838-30 Aphena 30 tablets — AB FDA listed —
Lisinopril and Hydrochlorothiazide 20 mg/1; 12.5 mg 71610-0868-60 Aphena 90 tablets — AB FDA listed —
Lisinopril/HCTZ 20 mg/1; 12.5 mg 72189-0651-30 Direct_Rx 30 tablets — 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

🏛️
2003
On the market since
Mar 2003
📍
2026
Currently FDA-listed
23 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.

What it looks like

Color pink / blue
ShapeRound
ImprintWATSON;862
Size1 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.

🧪 Avoiding an ingredient? See Lisinopril and Hydrochlorothiazide 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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 4AQJ3LG584
    A synthetic blue dye combined with aluminum to create a stable colorant. It's used in medicines and supplements to add blue color or create specific shades for product identification and appearance.
  • 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 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • 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.

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

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient 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.

Manufacturer & labeler

LabelerActavis Pharma, Inc.
Labeler code00591
First marketedMar 2003
Product typeDrug For Further Processing
Portfolio324 products on file

More NDCs from Actavis Pharma, Inc. labeler code 00591

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
580
Units reimbursed last 4 qtrs
30.2K
Gross reimbursed last 4 qtrs
$5.1K
Avg / prescription
$8.73
Avg / unit
$0.1674
Latest quarter Q1 2026
158Rx
Medicaid pays / ea
$0.1674
gross reimbursed
vs
NADAC / ea
$0.0361
acquisition cost
=
Spread
+$0.1313
+364% 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 ⓘ
52% FFS 48% MCO
Fee-for-service · 303 Rx Managed care · 277 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: 17,849 units · 91.2 per 100k residents 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: 520 units · 4.0 per 100k residents PA New Jersey: 1,320 units · 14.2 per 100k residents NJ Massachusetts: no data reported MA California: 720 units · 1.8 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 840 units · 18.6 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 4,830 units · 78.2 per 100k residents 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
1.891.2
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 New York 91.2 /100k
2 Maryland 78.2 /100k
3 Kentucky 18.6 /100k
4 New Jersey 14.2 /100k
5 Pennsylvania 4.0 /100k
6 California 1.8 /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 tablets this page00591-0861-01 580 Rx · $5,063
500 tablets00591-0861-05 431 Rx · $3,253
25000 tablets00591-0861-00 No Medicaid data
Drug total (last 4 qtrs): 1,011 Rx · 48,609 units · $8,316 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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: Actavis Pharma, Inc. 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 ✓ Available
Inactive ingredients (structured) ✓ 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 Actavis Pharma, Inc.. 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 2 other package presentations of this same product, including 500 tablets (00591-0861-05), 25000 tablets (00591-0861-00). 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?
Actavis Pharma, Inc. 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.
← 00591-0860-01 · Actavis 00591-0862-01 · Actavis →
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.