Hydralazine Hydrochloride 50 mg Tablet, 10-count
by Cardinal Health 107, LLC · 10 BLISTER PACK in 1 BAG (55154-0287-0) / 1 TABLET in 1 BLISTER PACK
NDC 55154-0287-00
🏷️ FDA NDC (as labeled)
55154-0287-0
billing pads the package segment with a zero
Rx only
Generic
On market
Non-controlled
🗂️ Data synced Sep 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
55154-0287-0
Product NDC
55154-0287
11-digit billing NDC
55154028700
Application #
ANDA088468
SPL Set ID
7dc89d53-ade0-40de-b7e3-d14f7151958d
Established class (EPC)
Arteriolar Vasodilator
Physiologic effect
Arteriolar Vasodilation
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2026-09-14
Route
ORAL
Dosage form
TABLET
Substance
HYDRALAZINE HYDROCHLORIDE
TE code (Orange Book)
AA · RLD · RS
Why two NDCs?
The FDA registers this code as 55154-0287-0 — 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 → 55154-0287-00. 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.
🏭 Manufacturer & labeler
LabelerCardinal Health 107, LLC
Application holderPLIVA INC
FDA applicationANDA088468 (ANDA)
Labeler code55154
First marketedSep 2026
Product typeHuman Prescription Drug
Portfolio477 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.
🩺 Clinical
📗 Our plain-language guide HelloPharmacist
- Hydralazine is a blood pressure–lowering medication. It works by relaxing the walls of your arteries so blood can flow through more easily, which brings your blood pressure down. K...
- What exactly is hydralazine supposed to do for me?
- Your prescription label and your doctor's instructions are the best guide for your specific regimen. Tablets are generally taken several times a day, and your doctor will have star...
- How do I take my hydralazine tablets — do they need to be taken with food?
Patient education
Supplement & herbal interactions
2
Nutrient depletion considerations
Hydralazine may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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.
💬 Questions about Hydralazine Hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
orange
ShapeRound
ImprintPLIVA;328
Size9 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
-
UNII GYP6Z2JR6Q
FD&C Yellow No. 6 Aluminum Lake is a yellow colorant made by combining FD&C Yellow No. 6 dye with aluminum salts. It's used to color tablets, capsules, and other medicines so they're easier to identify.
-
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
-
UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
5 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.
💲 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 system | Per each | Per 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. | |
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.
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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hydralazine Hydrochloride 50 mg 50111-0328-01 | Teva | 100 tablets | $0.046 | AA | Availability likely | — |
| Hydralazine Hydrochloride 50 mg 50228-0184-01 | ScieGen | 100 tablets | $0.046 | AA | Availability likely | — |
| HydrALAZINE Hydrochloride 50 mg 76282-0311-01 | Exelan | 100 tablets | $0.046 | — | Availability likely | — |
| Hydralazine Hydrochloride 50 mg 23155-0834-01 | Heritage | 100 tablets | $0.046 | AA | Availability likely | — |
| HydrALAZINE Hydrochloride 50 mg 64380-0735-06 | Strides | 100 tablets | $0.046 | — | Availability likely | — |
| Hydralazine Hydrochloride 50 mg 60687-0833-01 | American | 100 tablets | $0.046 | AA | Availability likely | — |
| Hydralazine Hydrochloride 50 mg 62135-0581-12 | Chartwell | 120 tablets | $0.046 | — | Availability likely | — |
| Hydralazine Hydrochloride 50 mg 00904-7449-61 | Major | 100 tablets | $0.046 | AA | Availability likely | — |
| Hydralazine Hydrochloride 50 mg 23155-0003-01 | Heritage | 100 tablets | $0.046 | — | Availability likely | — |
| Hydralazine Hydrochloride 50 mg 51079-0076-20 | Mylan | 100 tablets | $0.046 | AA | Availability likely | — |
| Hydralazine Hydrochloride 50 mg 31722-0521-01 | Camber | 100 tablets | $0.046 | AA | Availability likely | — |
| Hydralazine Hydrochloride 50 mg 67877-0291-01 | Ascend | 100 tablets | — | AA | FDA listed | — |
| HydrALAZINE Hydrochloride 50 mg 71205-0072-30 | Proficient | 30 tablets | — | — | FDA listed | — |
| Hydralazine 50 mg 75834-0127-00 | Nivagen | 1000 tablets | — | AA | Discontinued | — |
| Hydralazine Hydrochloride 50 mg 77771-0184-01 | Radha | 100 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 50090-6608-00 | A-S | 90 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 63629-8497-01 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 71209-0017-05 | Cadila | 100 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 71335-9756-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 50090-7212-00 | A-S | 90 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 51655-0916-26 | Northwind | 90 tablets | — | — | Discontinued | — |
| Hydralazine Hydrochloride 50 mg 63629-5246-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 71610-0562-60 | Aphena | 90 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 72241-0005-05 | Modavar | 100 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 43063-0392-90 | PD-Rx | 90 tablets | — | — | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 48433-0048-20 | Safecor | 100 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 50090-7210-01 | A-S | 60 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 67046-1517-03 | Coupler | 30 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 68462-0343-01 | Glenmark | 100 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 72162-1537-00 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 55154-2140-00 | Cardinal | 10 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 33342-0376-11 | Macleods | 100 tablets | — | — | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 50090-6684-00 | A-S | 90 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 55154-0187-00 | Cardinal | 10 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 70518-4007-00 | REMEDYREPACK | 30 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 68071-1940-03 | NuCare | 30 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 55154-5085-00 | Cardinal | 10 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 50090-0139-00 | A-S | 100 tablets | — | AA | Discontinued | — |
| HydrALAZINE Hydrochloride 50 mg 67046-2080-03 | Coupler | 30 tablets | — | — | FDA listed | — |
| Hydralazine Hydrochloride 50 mgthis 55154-0287-00 | Cardinal | 10 tablets | — | AA | FDA listed | — |
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
⏳ Availability & generic status
🏛️
2026
On the market since
Sep 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
🔬 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 Hydralazine Hydrochloride — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 46%
Female · 54%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 55154-0287-00 You're viewing this | 10 BLISTER PACK in 1 BAG (55154-0287-0) / 1 TABLET in 1 BLISTER PACK | 2026-09-14 | Active |
🧭 About this NDC listing & data coverage
Finished prescription product
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) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| 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 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.
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 FDA registers it as 55154-0287-0, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 55154-0287-00, written without dashes as 55154028700. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 55154-0287-00, the first segment (55154) is the labeler code FDA assigned to Cardinal Health 107, LLC; the middle segment (0287) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Cardinal Health 107, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cardinal Health 107, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 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 ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.