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Papaverine Hydrochloride 1 g/g Powder, 100 g — NDC 38779-0454-5 (Billing 38779-0454-05)

by Medisca Inc. · 100 g in 1 JAR

This is a package of 100 g of Papaverine Hydrochloride 1 g/g Powder from Medisca Inc., marketed since Jul 2014 and currently FDA-listed.

NDC 38779-0454-05
🏷️ FDA NDC (as labeled) 38779-0454-5 billing pads the package segment with a zero
This package
Contains100 g Pack sizes5 compare ↓
Product page 38779-0454-03 Also comes in: 5 g 38779-0454-3 25 g 38779-0454-4 500 g 38779-0454-8 1000 g 38779-0454-9
On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Papaverine Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Jul 24, 2026 — Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde (American Regent, Inc.) · FDA recall D-0800-2026
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) 38779-0454-5
Product NDC 38779-0454
11-digit billing NDC 38779045405
SPL Set ID 453d9790-c2ca-7077-e063-6394a90aac63
DEA schedule Non-controlled
Marketing category BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-07-07
Dosage form POWDER
Substance PAPAVERINE HYDROCHLORIDE

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

GPI-14 40100060102900
GPI class Papaverine HCl
GCN Seq No 000528
GCN 02110
HICL code 000170
Ingredient (HICL) Papaverine Hcl
HIC1 code U
Therapeutic class — broad (HIC1) Miscell. Drugs/ Pharmaceutical Adjuvants
HIC2 code U6
Therapeutic class — intermediate (HIC2) Pharmaceutical Adjuvants
HIC3 code U6W
Therapeutic class — specific (HIC3) Bulk Chemicals
AHFS code 24:12.92.00
AHFS class Vasodilating Agents, Miscellaneous
FDB label name PAPAVERINE HCL POWDER
FDB brand name Papaverine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 000528
  • GCN: 02110
  • GPI-14 (Medi-Span): 40100060102900
  • HICL (First Databank): 000170
  • AHFS class code: 24:12.92.00
Why two NDCs? The FDA registers this code as 38779-0454-5 — a 5-4-1 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 package segment → 38779-0454-05. 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 PAPAVERINE HCL POWDER Ingredient Papaverine Hcl
📗 Our plain-language guide HelloPharmacist
  • It relaxes smooth muscle, so it is used when spasm is part of the problem. That includes blood vessel spasm with heart attack, angina, or clots in the arteries of the limbs or lung...
  • It is injected into a vein or a muscle by a healthcare professional. When it goes into a vein, it should be given slowly over 1 to 2 minutes to avoid uncomfortable side effects. Yo...
  • Some people notice nausea, stomach discomfort, headache, flushing, sweating, or dizziness. Tell your care team if these bother you. Let them know right away about anything that see...
  • People with complete atrioventricular heart block should not get it by vein, because it can cause abnormal heart rhythms. Make sure your care team knows your heart history.
📖 Read our full Papaverine 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 gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J2440 No ASP payment limit on file for J2440 this quarter.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 5 g 25 g 500 g 1000 g
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.

Billing & reimbursement

FDA NDC (as labeled)38779-0454-5
11-digit billing NDC38779-0454-05
Format5-4-1 as registered → padded to 5-4-2 for billing (zero added to the package segment)
HCPCS J-codeJ2440
DescriptorINJECTION, PAPAVERINE HCL, UP TO 60 MG
Billing units / pkg16.67 units
How the units are derivedThis package is 1 EA; the HCPCS unit is 60 MG, so one package = 16.67 billing units.
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
38779-0454-03 38779-0454-3 Main listing 5 g in 1 BOTTLE, GLASS — — Active
38779-0454-04 38779-0454-4 25 g in 1 JAR — — Active
38779-0454-05 You're viewing this 100 g in 1 JAR — — Active
38779-0454-08 38779-0454-8 500 g in 1 JAR — — Active
38779-0454-09 38779-0454-9 1000 g in 1 JAR — — Active

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

Pack size FAQ

What quantity is in this package?
This package contains 100 g — 100 g in 1 jar.
How does this package differ from NDC 38779-0454-03?
Both are Papaverine Hydrochloride 1 g/g Powder — the drug itself is identical. This page's package is the 100 g one, while NDC 38779-0454-03 is the 5 g package.
What NDC number is used to bill for this package of Papaverine Hydrochloride 1 g/g Powder?
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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Papaverine Hydrochloride 1 g/g 70859-0101-01 NuCare 1 g — — FDA listed —
Papaverine Hydrochloride 1 g/g 62991-1203-02 LETCO 25 g — — FDA listed —
Papaverine Hydrochloride 1 g/gthis 38779-0454-05 Medisca 100 g — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2014
On the market since
Jul 2014
📍
2026
Currently FDA-listed
12 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

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

LabelerMedisca Inc.
Labeler code38779
First marketedJul 2014
Product typeBulk Ingredient
Portfolio285 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 ↗

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 PAPAVERINE HYDROCHLORIDE — the ingredient across all brands.

Top reported reactions

Drug Interaction24
Toxicity To Various Agents24
Hypotension23
Constipation19
Pain17
Balance Disorder15
Blood Calcium Decreased15

Age at onset

Adult6
Elderly8

Reporter sex

99 reports
Male · 53%
Female · 46%
Unknown · 1%

Serious outcomes

Hospitalization45
Life-threatening27
Death17
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 16 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

Bulk ingredient (not a finished retail product)

This is a bulk ingredient listing — not a retail prescription package

Papaverine Hydrochloride 1 g/g POWDER is listed with FDA as a bulk ingredient (a drug substance supplied for further manufacturing or licensed pharmacy compounding). It is not a finished product a patient would receive at a retail pharmacy, so consumer-style information — a patient label, retail pricing, package photos — generally does not exist for this NDC. The listing identifies the substance and package for supply-chain and regulatory purposes.

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) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Bulk Ingredient For Human Prescription Compounding". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Can I get this product filled at a pharmacy?
Not as listed here. A bulk ingredient NDC identifies drug substance supplied for manufacturing or licensed compounding — it is not a finished, dispensable package. A pharmacy prescription would involve a finished product with its own NDC.
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 Medisca 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 4 other package presentations of this same product, including 5 g (38779-0454-03), 25 g (38779-0454-04), 500 g (38779-0454-08). 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?
Medisca 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J2440 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
← 38779-0452-02 · Medisca 38779-0458-04 · Medisca →
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.