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GLATIRAMER ACETATE 40 mg/mL Injection, Solution, 12 syringes — NDC 11797-765-03 (Billing 11797-0765-03)

by Italfarmaco SpA · 12 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE

This is a package of 12 syringes of GLATIRAMER ACETATE 40 mg/mL Injection, Solution from Italfarmaco SpA, marketed since Nov 2025 and currently FDA-listed. It is this product's only package size.

NDC 11797-0765-03
🏷️ FDA NDC (as labeled) 11797-765-03 billing pads the product segment with a zero
Rx only Generic 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 11797-765-03
Product NDC 11797-765
11-digit billing NDC 11797076503
RxCUI 1111641, 1487361
UNII 5M691HL4BO
Application # ANDA208468
SPL Set ID 1b3a60de-2191-4b15-be69-01329da87711
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-11-10
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance GLATIRAMER ACETATE
TE code (Orange Book) AP · RLD · RS
Quick answers
  • RxCUI (RxNorm): 1111641
Why two NDCs? The FDA registers this code as 11797-765-03 — a 5-3-2 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 product segment → 11797-0765-03. 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.

RxNorm drug class

This medicine belongs to the Other immunostimulants class.

Drug family (ATC) Other immunostimulants
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It's a treatment for relapsing forms of multiple sclerosis (MS) in adults. That includes a first episode that might signal MS (called clinically isolated syndrome), the classic rel...
  • What exactly is glatiramer acetate used for?
  • Yes, where you inject absolutely matters. You inject under the skin — never into a vein — and you should rotate your injection sites every single time. Good spots include your uppe...
  • How do I give myself the injection, and does it matter where I inject?
📖 Read our full Glatiramer Injection guide →
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 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 · Q2 2026 $82.00 $984.00 / 12 ml
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
11797-0765-03 You're viewing this Main listing 12 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE 2025-11-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Glatiramer Acetate 40 mg/mL 00378-6961-12 Mylan 1 syringe $86.095 AP Availability likely —
Glatopa 40 mg/mL 00781-3250-89 Sandoz 1 syringe $86.095 AP Availability likely —
Glatiramer Acetate 40 mg/mL 00832-6085-12 UPSHER-SMITH 12 syringes $86.095 AP Availability likely —
Glatiramer Acetate 40 mg/mL 47335-0991-02 Sun 1 syringe $86.095 AP Availability likely —
Glatiramer Acetate 40 mg/mL 70710-1549-06 Zydus 1 syringe $86.095 AP Availability likely —
Glatiramer Acetate 40 mg/mLthis 11797-0765-03 Italfarmaco 12 syringes — AP FDA listed —
Glatopa 40 mg/mL 63629-8816-01 Bryant 1 syringe — AP FDA listed —
Copaxone 40 mg/mL 68546-0325-06 Teva 1 syringe — AP FDA listed —
Glatiramer Acetate 40 mg/mL 82983-0430-12 AJENAT 1 syringe — AP 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

🏛️
2025
On the market since
Nov 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
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.

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

LabelerItalfarmaco SpA
Application holderCHEMI SPA
FDA applicationANDA208468 (ANDA)
Labeler code11797
First marketedNov 2025
Product typeHuman Prescription Drug
Portfolio11 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 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.
📄 Package Label / Principal Display Panel
📄 Package Label / Principal Display Panel 120 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 11797-764-03 ONCE DAILY Glatiramer Acetate Injection 20 mg/mL FOR SUBCUTANEOUS INJECTION ONLY 30 pre-filled syringe (3 carton box of 10 syringes) Each pre-filled syringe contains 1 mL Glatiramer Acetate Injection solution of: glatiramer acetate 20 mg, mannitol 40 mg (inactive ingredient). Dispense the enclosed Medication Guide to each patient zydus Pharmaceuticals USA Rx only NDC 11797-765-03 THREE TIMES A WEEK Glatiramer Acetate Injection 40 mg/mL FOR SUBCUTANEOUS INJECTION ONLY 12 Single Dose Pre-Filled Syringes Each pre-filled syringe contains 1 mL Glatiramer Acetate Injection solution of: glatiramer acetate 40 mg, mannitol 40 mg (inactive ingredient).

Dispense the enclosed Medication Guide to each patient zydus Pharmaceuticals USA Rx only 20 mg container label 20 mg container label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Glatiramer Acetate — the program that covers self-administered drugs. 3 manufacturers.
⚠️ 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 Glatiramer Acetate. 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
$17.32M
Claims incl. refills
8K
Beneficiaries
3.2K
Spend / beneficiary
$5,366.30
Spend / claim
$2,158.43
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.

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 — 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 ✓ 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 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 Italfarmaco SpA. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Italfarmaco SpA 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.
← 11797-0764-03 · Italfarmaco 11822-0005-01 · Rite →
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.