NDC codes

FDA NDC Directory
Product NDC (as listed)70710-1549Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70710-1549Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
70710-1549-6707101549067071015490612 BLISTER PACK in 1 CARTON (70710-1549-6) / 1 SYRINGE in 1 BLISTER PACK / 1 mL in 1 SYRINGE (70710-1549-2)Marketed from Nov 10, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Glatiramer Acetate
Generic name (nonproprietary)
glatiramer acetate
Active ingredients
Glatiramer acetate — 40 mg/mL
Dosage form
Injection, Solution
Route
Subcutaneous
Labeler
Zydus Pharmaceuticals USA Inc.NDC labeler code 70710
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208468
Marketing start
Listing expires
Identifiers
Product ID 70710-1549_fe3feaf2-7856-4040-a0fe-4c7be5f3ebbaSPL ID fe3feaf2-7856-4040-a0fe-4c7be5f3ebbaSPL set ID 0aa4ff2a-ce8e-46cd-830f-a264cc582be2RxCUI 1111641, 1487361UNII 5M691HL4BOUPC 0370710154967, 0370710154899

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N470710154906 followed by a unit qualifier and the quantity

Package 70710-1549-06. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

Glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70710-1549

What is NDC 70710-1549?
70710-1549 is the product NDC for Glatiramer Acetate, Glatiramer acetate 40 mg/mL injection, solution, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Glatiramer Acetate.
What is the active ingredient?
Glatiramer acetate.
Who is the labeler?
Zydus Pharmaceuticals USA Inc., NDC labeler code 70710. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Glatiramer Acetate?
11 other product NDCs are listed under this name. See all Glatiramer Acetate NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Glatiramer Acetate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Glatiramer AcetateGlatiramer acetate 20 mg/mLInjection, SolutionSubcutaneousAJENAT PHARMACEUTICALS LLC82983-42982983-0429-30
Glatiramer AcetateGlatiramer acetate 40 mg/mLInjection, SolutionSubcutaneousAJENAT PHARMACEUTICALS LLC82983-43082983-0430-12
Glatiramer Acetateglatiramer acetate injectionGlatiramer acetate 20 mg/mLInjection, SolutionSubcutaneousUPSHER-SMITH LABORATORIES, LLC0832-608400832-6084-30
Glatiramer Acetateglatiramer acetate injectionGlatiramer acetate 40 mg/mLInjection, SolutionSubcutaneousUPSHER-SMITH LABORATORIES, LLC0832-608500832-6085-12
Glatiramer AcetateGlatiramer acetate 20 mg/mLInjection, SolutionSubcutaneousItalfarmaco SpA11797-76411797-0764-03
Glatiramer AcetateGlatiramer acetate 40 mg/mLInjection, SolutionSubcutaneousItalfarmaco SpA11797-76511797-0765-03
Glatiramer AcetateGlatiramer acetate 20 mg/mLInjection, SolutionSubcutaneousZydus Pharmaceuticals USA Inc.70710-154870710-1548-09
Glatiramer AcetateGlatiramer acetate 20 mg/mLInjection, SolutionSubcutaneousSun Pharmaceutical Industries, Inc.47335-99047335-0990-02
Glatiramer AcetateGlatiramer acetate 40 mg/mLInjection, SolutionSubcutaneousSun Pharmaceutical Industries, Inc.47335-99147335-0991-02
Glatiramer AcetateGlatiramer acetate 20 mg/mLInjection, SolutionSubcutaneousMylan Pharmaceuticals Inc.0378-696000378-6960-93

All 12 Glatiramer Acetate NDCs

Other NDCs under ANDA 208468

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 208468
ProductStrengthForm · routeLabelerProduct NDC
Glatiramer AcetateGlatiramer acetate 20 mg/mLInjection, SolutionSubcutaneousItalfarmaco SpA11797-764
Glatiramer AcetateGlatiramer acetate 40 mg/mLInjection, SolutionSubcutaneousItalfarmaco SpA11797-765
Glatiramer AcetateGlatiramer acetate 20 mg/mLInjection, SolutionSubcutaneousZydus Pharmaceuticals USA Inc.70710-1548

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