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RhoGAM Ultra-Filtered PLUS HUMAN RHO(D) IMMUNE GLOBULIN 300 ug Injection, Solution, 1 pouch — NDC 0562-7805-01 (Billing 00562-7805-01)

by Kedrion Biopharma Inc · 1 POUCH in 1 CARTON / 1 INJECTION, SOLUTION in 1 POUCH

This is a package of 1 pouch of RhoGAM Ultra-Filtered PLUS HUMAN RHO(D) IMMUNE GLOBULIN 300 ug Injection, Solution from Kedrion Biopharma Inc, marketed since Mar 2007 and currently FDA-listed.

NDC 00562-7805-01
🏷️ FDA NDC (as labeled) 0562-7805-01 billing pads the labeler segment with a zero
This package
Contains1 pouch Medicaid pays$36.39 / unit · 12 mo Pack sizes3 compare ↓
Product page 00562-7805-05 Also comes in: 5 pouches 0562-7805-05 25 pouches 0562-7805-25
Brand 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) 0562-7805-01
Product NDC 0562-7805
11-digit billing NDC 00562780501
NCPDP billing unit EA — each (per item)
Application # BLA103777
SPL Set ID 7ccbaf67-ab6a-490a-9b63-598d75a7afca
Established class (EPC) Human Immunoglobulin G
Mechanism of action Endogenous Antigen Neutralization
Physiologic effect Passively Acquired Immunity
Chemical class Immunoglobulins
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-03-09
Route INTRAMUSCULAR
Dosage form INJECTION, SOLUTION
Substance HUMAN RHO(D) IMMUNE GLOBULIN
Biologic (Purple Book) 351(a)

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

GPI-14 1910005000E540
GPI class RhoGAM Ultra-Filtered Plus
GCN Seq No 045802
GCN 91398
HICL code 004209
Ingredient (HICL) Rho(D) Immune Globulin
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W7
Therapeutic class — intermediate (HIC2) Biologicals
HIC3 code W7K
Therapeutic class — specific (HIC3) Antisera
AHFS code 80:04.00.00
AHFS class Antitoxins And Immune Globulins
FDB label name RHOGAM ULTRA-FILTERED PLUS SYR
FDB brand name Rhogam Ultra-Filtered Plus
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 045802
  • GCN: 91398
  • GPI-14 (Medi-Span): 1910005000E540
  • HICL (First Databank): 004209
  • AHFS class code: 80:04.00.00
Why two NDCs? The FDA registers this code as 0562-7805-01 — 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 → 00562-7805-01. 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 RHOGAM ULTRA-FILTERED PLUS SYR Ingredient Rho(D) Immune Globulin

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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $36.39 —
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J2790 $85.125 / J2790 unit —
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)0562-7805-01
11-digit billing NDC00562-7805-01
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ2790
DescriptorINJECTION, RHO D IMMUNE GLOBULIN, HUMAN, FULL DOSE, 300 MICROGRAMS (1500 I.U.)
Billing units / pkg1 units
How the units are derivedThis package is 1 EA; the HCPCS unit is 300 MCG, so one package = 1 billing unit.
Medicare Part B spend (2026 (Q1))$2,231 · 29 claims · $76.92 per claim (all NDCs under J2790)
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
00562-7805-01 You're viewing this 1 POUCH in 1 CARTON / 1 INJECTION, SOLUTION in 1 POUCH 2007-03-09 — Active
00562-7805-05 0562-7805-05 Main listing 5 POUCH in 1 CARTON / 1 INJECTION, SOLUTION in 1 POUCH 2007-03-09 — Active
00562-7805-25 0562-7805-25 25 POUCH in 1 CARTON / 1 INJECTION, SOLUTION in 1 POUCH 2007-03-09 — Active

This pack accounts for about 30% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 1 pouch — 1 pouch in 1 carton / 1 injection, solution in 1 pouch.
How does this package differ from NDC 00562-7805-05?
Both are RhoGAM Ultra-Filtered PLUS HUMAN RHO(D) IMMUNE GLOBULIN 300 ug Injection, Solution — the drug itself is identical. This page's package is the 1 pouch one, while NDC 00562-7805-05 is the 5 pouches package.
What NDC number is used to bill for this package of RhoGAM Ultra-Filtered PLUS HUMAN RHO(D) IMMUNE GLOBULIN 300 ug Injection, Solution?
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
RhoGAM Ultra-Filtered PLUS 300 ugthis 00562-7805-01 Kedrion 1 pouch — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
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 & biosimilar status

🏛️
1998
First FDA approval
Apr 1998
📍
2026
Currently FDA-listed
28 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar 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

LabelerKedrion Biopharma Inc
FDA applicationBLA103777 (BLA)
Labeler code00562
First marketedMar 2007
Product typePlasma Derivative
Portfolio2 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
5.5K
Units reimbursed last 4 qtrs
13.3K
Gross reimbursed last 4 qtrs
$483.3K
Avg / prescription
$88.17
Avg / unit
$36.3918
Latest quarter Q1 2026
955Rx
Fee-for-service vs managed care ⓘ
18% FFS 82% MCO
Fee-for-service · 1,000 Rx Managed care · 4,481 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: 49 units · 0.5 per 100k residents MI New York: 432 units · 2.2 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 56 units · 1.3 per 100k residents OR Nevada: 70 units · 2.2 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 85 units · 2.7 per 100k residents IA Illinois: 245 units · 2.0 per 100k residents IL Indiana: 194 units · 2.8 per 100k residents IN Ohio: 215 units · 1.8 per 100k residents OH Pennsylvania: 156 units · 1.2 per 100k residents PA New Jersey: 60 units · 0.6 per 100k residents NJ Massachusetts: 2 units · 0.0 per 100k residents MA California: 353 units · 0.9 per 100k residents CA Utah: 3,009 units · 88.1 per 100k residents UT Colorado: 84 units · 1.4 per 100k residents CO Nebraska: no data reported NE Missouri: 156 units · 2.5 per 100k residents MO Kentucky: 220 units · 4.9 per 100k residents KY West Virginia: no data reported WV Virginia: 95 units · 1.1 per 100k residents VA Maryland: 4,820 units · 78.0 per 100k residents MD Connecticut: 261 units · 7.2 per 100k residents CT Rhode Island: no data reported RI Arizona: 145 units · 2.0 per 100k residents AZ New Mexico: no data reported NM Kansas: 20 units · 0.7 per 100k residents KS Arkansas: 90 units · 2.9 per 100k residents AR Tennessee: 365 units · 5.1 per 100k residents TN North Carolina: 88 units · 0.8 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 220 units · 5.4 per 100k residents OK Louisiana: 39 units · 0.9 per 100k residents LA Mississippi: 49 units · 1.7 per 100k residents MS Alabama: 102 units · 2.0 per 100k residents AL Georgia: 182 units · 1.7 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 769 units · 2.5 per 100k residents TX Florida: 613 units · 2.7 per 100k residents FL
Units reimbursed · per 100k residents
0.088.1
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 Utah 88.1 /100k
2 Maryland 78.0 /100k
3 Connecticut 7.2 /100k
4 Oklahoma 5.4 /100k
5 Tennessee 5.1 /100k
6 Kentucky 4.9 /100k
7 Arkansas 2.9 /100k
8 Indiana 2.8 /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.
5 pouches00562-7805-05 11,341 Rx · $989,863
1 pouch this page00562-7805-01 5,481 Rx · $483,251
25 pouches00562-7805-25 1,299 Rx · $114,721
Drug total (last 4 qtrs): 18,121 Rx · 45,142 units · $1,587,836 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

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) ✓ 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

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 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 Kedrion Biopharma 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 5 pouches (00562-7805-05), 25 pouches (00562-7805-25). 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?
Kedrion Biopharma 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 J2790 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.
← 00555-9131-67 · TEVA 00573-0133-01 · Haleon →
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.