Home › NDC Lookup › Ingredients › Clonazepam › 00004-0058-01
⚪image loading
(from DailyMed)

Klonopin Clonazepam 1 mg Tablet, 100-count — NDC 0004-0058-01 (Billing 00004-0058-01)

by Genentech, Inc. · 100 TABLET in 1 BOTTLE, PLASTIC

This is a package of 100 tablets of Klonopin Clonazepam 1 mg Tablet from Genentech, Inc., no longer marketed, no longer in the FDA NDC Directory; retail pharmacies pay about $2.78 per tablet (NADAC). It is this product's only package size.

NDC 00004-0058-01
🏷️ FDA NDC (as labeled) 0004-0058-01 billing pads the labeler segment with a zero
Rx only Brand Discontinued CIV ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 0004-0058-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0004 labeler · 0058 product · 01 package
Billing quantity
100 EA per package
Barcode (UPC-A, from the NDC)
3 0004005801 7
FDA record last changed
Mar 13, 2024
⚠️
Other active recalls for Clonazepam (different manufacturers) — 4 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Nov 18, 2024 — Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. (Endo USA, Inc.) · FDA recall D-0179-2025
Class I · Nov 18, 2024 — Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. (Endo USA, Inc.) · FDA recall D-0181-2025
Class I · Nov 18, 2024 — Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. (Endo USA, Inc.) · FDA recall D-0178-2025
Class I · Nov 18, 2024 — Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. (Endo USA, Inc.) · FDA recall D-0180-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
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 Feb 2024. 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) 0004-0058-01
Product NDC 0004-0058
11-digit billing NDC 00004005801
NCPDP billing unit EA — each (per item)
Application # NDA017533
Chemical class Benzodiazepine [EPC], Benzodiazepines
DEA schedule CIV
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Feb 2024)
Route ORAL
Dosage form TABLET
Substance CLONAZEPAM
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 004561
GCN 17471
HICL code 001894
Ingredient (HICL) Clonazepam
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H4
Therapeutic class — intermediate (HIC2) Anticonvulsants
HIC3 code H4A
Therapeutic class — specific (HIC3) Anticonvulsant - Benzodiazepine Type
AHFS code 28:12.08.00
AHFS class Benzodiazepines (Anticonvulsants)
FDB label name KLONOPIN 1 MG TABLET
FDB brand name Klonopin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004561
  • GCN: 17471
  • HICL (First Databank): 001894
  • AHFS class code: 28:12.08.00
Why two NDCs? The FDA registers this code as 0004-0058-01 — 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 → 00004-0058-01. 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 KLONOPIN 1 MG TABLET Ingredient Clonazepam
📗 Our plain-language guide HelloPharmacist
  • It treats certain seizure disorders and panic disorder. Your prescriber will tell you which applies to you.
  • Take it by mouth exactly as prescribed. Swallow regular tablets whole with water. If you have the orally disintegrating tablet, place it on your tongue with dry hands and let it di...
  • Please don't stop suddenly. Your body can become dependent, and abrupt stopping can cause serious withdrawal, including seizures. Your prescriber will lower the dose gradually.
  • Drowsiness, unsteadiness and dizziness are the most common. Let me know if you notice mood changes, depression, thoughts of self-harm, agitation or aggression, because those need p...
📖 Read our full Clonazepam guide →
1
Nutrient depletion considerations

Clonazepam may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Clonazepam 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 $2.785 $278.48 / 100 tablets
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
Aug 2021 Apr 2022 Mar 2023 $2.806 $2.785
Flat over the last 3 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 Marketing startMarketing endStatus
00004-0058-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE, PLASTIC 2010-09-04 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clonazepam 1 mg 00093-3212-01 Teva 100 tablets $0.024 AB Availability likely save 99%
Clonazepam 1 mg 00904-7728-61 Major 100 tablets $0.024 AB Availability likely save 99%
Clonazepam 1 mg 16729-0137-00 Accord 100 tablets $0.024 AB Availability likely save 99%
Clonazepam 1 mg 43547-0407-10 Solco 100 tablets $0.024 AB Availability likely save 99%
Clonazepam 1 mg 50268-0174-15 AvPAK 50 tablets $0.024 AB Availability likely save 99%
Clonazepam 1 mg 59651-0723-01 Aurobindo 100 tablets $0.024 — Availability likely save 99%
Clonazepam 1 mg 60687-0872-01 American 100 tablets $0.024 AB Availability likely save 99%
Clonazepam 1 mg 62135-0770-90 Chartwell 90 tablets $0.024 AB Availability likely save 99%
Clonazepam 1 mg 72603-0308-01 Northstar 100 tablets $0.024 AB Availability likely save 99%
Clonazepam 1 mg 72888-0153-00 Advagen 1000 tablets $0.024 AB Availability likely save 99%
Klonopin 1 mgthis 00004-0058-01 Genentech, 100 tablets $2.785 AB Discontinued —
Klonopin 1 mg 61269-0610-10 H2-Pharma, 100 tablets $3.054 AB Availability likely +10%
Clonazepam 1 mg 43063-0794-30 PD-Rx 30 tablets — AB FDA listed —
Clonazepam 1 mg 50090-2022-00 A-S 60 tablets — AB Discontinued —
Clonazepam 1 mg 55154-4319-00 Cardinal 100 tablets — AB FDA listed —
Clonazepam 1 mg 58118-0153-08 Clinical 30 tablets — AB FDA listed —
Clonazepam 1 mg 60760-0300-30 St 30 tablets — AB FDA listed —
Clonazepam 1 mg 63187-0888-30 Proficient 30 tablets — AB FDA listed —
Clonazepam 1 mg 63629-1116-01 Bryant 100 tablets — AB FDA listed —
Clonazepam 1 mg 63629-1204-01 Bryant 500 tablets — AB Discontinued —
Clonazepam 1 mg 63629-1205-01 Bryant 1000 tablets — AB FDA listed —
Clonazepam 1 mg 63629-8988-01 Bryant 30 tablets — AB FDA listed —
Clonazepam 1 mg 67046-0493-03 Coupler 30 tablets — AB FDA listed —
Clonazepam 1 mg 67046-0794-03 Coupler 30 tablets — AB FDA listed —
Clonazepam 1 mg 68071-5247-09 NuCare 90 tablets — AB FDA listed —
Clonazepam 1 mg 68788-8401-02 Preferred 20 tablets — AB FDA listed —
Clonazepam 1 mg 68788-8473-02 Preferred 20 tablets — AB FDA listed —
Clonazepam 1 mg 70518-1521-01 REMEDYREPACK 100 tablets — AB FDA listed —
Clonazepam 1 mg 70518-2334-00 REMEDYREPACK 100 tablets — AB FDA listed —
Clonazepam 1 mg 70518-2533-00 REMEDYREPACK 30 tablets — AB Discontinued —
Clonazepam 1 mg 70518-3144-00 REMEDYREPACK 100 tablets — AB FDA listed —
Clonazepam 1 mg 70518-4074-00 REMEDYREPACK 30 tablets — AB FDA listed —
Clonazepam 1 mg 71205-0529-30 Proficient 30 tablets — AB FDA listed —
Clonazepam 1 mg 71335-0022-00 Bryant 100 tablets — AB FDA listed —
Clonazepam 1 mg 71335-1843-00 Bryant 100 tablets — AB FDA listed —
Clonazepam 1 mg 71335-2414-00 Bryant 100 tablets — AB FDA listed —
Clonazepam 1 mg 71610-0040-30 Aphena 30 tablets — AB FDA listed —
Clonazepam 1 mg 71610-0771-15 Aphena 15 tablets — AB FDA listed —
Clonazepam 1 mg 71610-0852-12 Aphena 12 tablets — AB FDA listed —
Clonazepam 1 mg 72189-0475-30 Direct_Rx 30 tablets — AB FDA listed —
Clonazepam 1 mg 72789-0314-30 PD-Rx 30 tablets — AB FDA listed —
Clonazepam 1 mg 80425-0135-01 Advanced 30 tablets — AB FDA listed —
Clonazepam 1 mg 80425-0357-01 Advanced 30 tablets — AB FDA listed —
Clonazepam 1 mg 82804-0272-30 Proficient 30 tablets — AB FDA listed —
Clonazepam 1 mg 87441-0022-01 Unit 30 tablets — AB FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be 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

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

🧪 Avoiding an ingredient? See Clonazepam 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.

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

LabelerGenentech, Inc.
Application holderCHEPLAPHARM ARZNEIMITTEL GMBH
FDA applicationNDA017533 (NDA)
Labeler code00004
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio93 products on file

More NDCs from Genentech, Inc. labeler code 00004

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 Klonopin — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Klonopin. 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
$765.4K
Claims incl. refills
3.7K
Beneficiaries
1.8K
Spend / beneficiary
$436.64
Spend / claim
$208.05
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.

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 Klonopin (this brand).

Top reported reactions

Fatigue10,476
Nausea9,821
Anxiety8,893
Headache8,759
Depression8,232
Pain8,224
Dizziness7,400

Age at onset

Neonate212
Infant161
Child399
Adolescent334
Adult12,315
Elderly4,853

Reporter sex

159,281 reports
Male · 35%
Female · 65%
Unknown · 0%

Serious outcomes

Hospitalization47,309
Life-threatening6,317
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 11,027 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

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 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 ✓ 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.
Who lists this product with the FDA?
Genentech, 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.
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.
← 00003-7125-11 · E.R. 00004-0259-01 · Genentech, →
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.