NDC codes

FDA NDC Directory
Product NDC (as listed)0115-1694Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00115-1694Add 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
0115-1694-30001151694301 CASE in 1 CARTON (0115-1694-30) / 1 SYRINGE, GLASS in 1 CASE / .3 mL in 1 SYRINGE, GLASSMarketed from Apr 1, 2010
0115-1694-49001151694492 CASE in 1 CARTON (0115-1694-49) / 1 SYRINGE, GLASS in 1 CASE / .3 mL in 1 SYRINGE, GLASSMarketed from Apr 1, 2010

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
epinephrine
Generic name (nonproprietary)
epinephrine
Active ingredients
Epinephrine — .3 mg/.3mL
Dosage form
Injection
Route
Subcutaneous
Labeler
Amneal Pharmaceuticals of New York LLCNDC labeler code 0115
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 020800
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Catecholamines (Chemical structure)
Identifiers
Product ID 0115-1694_fdafd090-bed3-4f16-8ab1-fd1573aa633eSPL ID fdafd090-bed3-4f16-8ab1-fd1573aa633eSPL set ID e13f05f1-7d21-49bb-b8d5-24bf9301c3d7RxCUI 1870225, 1870230UNII YKH834O4BHUPC 0301151694491, 0301151695498
Pharmacologic class
Catecholamine; alpha-Adrenergic Agonist; beta-Adrenergic Agonist

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 codeMed-Code curated

J0171 — Injection, adrenalin, epinephrine, 0.1 mg

Billing unit: 0.1 mg. Units on the claim = dose given ÷ 0.1 mg.

Applies when epinephrine is administered in a clinical setting. Auto-injectors dispensed to patients are billed by NDC through a pharmacy benefit.

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

N400115169430 followed by a unit qualifier and the quantity

Package 00115-1694-30. 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 .

Indications (excerpt from the label)

Epinephrine Injection is indicated for the emergency treatment of type I allergic reactions, including anaphylaxis in adult and pediatric patients who weigh 15 kg or greater. Epinephrine Injection is a alpha and beta-adrenergic receptor agonist, indicated for the emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 15 kg or greater. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0115-1694

What is NDC 0115-1694?
0115-1694 is the product NDC for epinephrine, Epinephrine .3 mg/.3mL injection, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
epinephrine.
What is the active ingredient?
Epinephrine.
Who is the labeler?
Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for epinephrine?
74 other product NDCs are listed under this name. See all epinephrine NDCs.
Is there a related HCPCS / J-code?
Yes: J0171, Injection, adrenalin, epinephrine, 0.1 mg. See Billing references above.

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

Other epinephrine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
epinephrineEpinephrine 1 mg/mLInjectionIntramuscular, Intravenous, SubcutaneousGland Pharma Limited68083-69968083-0699-1068083-0699-25
EpinephrineEpinephrine 1 mg/mLInjectionIntramuscular, Intravenous, SubcutaneousHikma Pharmaceuticals USA Inc.0143-947600143-9476-25
EpinephrineEpinephrine 1 mg/mLInjectionIntramuscular, Intravenous, SubcutaneousHF Acquisition Co LLC, DBA HealthFirst51662-170851662-1708-03
epinephrineEpinephrine 1 mg/mLInjection, Solution, ConcentrateIntramuscular, Intravenous, SubcutaneousBaxter Healthcare Corporation43066-80143066-0801-02
epinephrineEpinephrine 1 mg/mLInjection, Solution, ConcentrateIntramuscular, Intravenous, SubcutaneousBaxter Healthcare Corporation43066-80343066-0803-25
epinephrineEpinephrine bitartrate 16 ug/mLInjection, SolutionIntravenousBaxter Healthcare Corporation0338-000600338-0006-20
epinephrineEpinephrine .15 mg/.15mLInjectionSubcutaneousREMEDYREPACK INC.70518-457370518-4573-00
epinephrineEpinephrine 1 mg/mLInjectionIntramuscular, Intravenous, SubcutaneousGLENMARK PHARMACEUTICALS INC., USA68462-76168462-0761-30
EpinephrineEpinephrine 1 mg/mLInjectionIntramuscular, Intravenous, SubcutaneousAmneal Pharmaceuticals Private Limited80830-165980830-1659-02
epinephrineEpinephrine 1 mg/mLInjectionIntramuscular, Intravenous, SubcutaneousAmneal Pharmaceuticals LLC70121-166070121-1660-02

All 75 epinephrine NDCs

Other NDCs under NDA 020800

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

FDA NDC Directory listings under NDA 020800
ProductStrengthForm · routeLabelerProduct NDC
EpinephrineEpinephrine .15 mg/.15mLInjectionSubcutaneousHF Acquisition Co LLC, DBA HealthFirst51662-1222
EpinephrineEpinephrine .3 mg/.3mLInjectionSubcutaneousHF Acquisition Co LLC, DBA HealthFirst51662-1223
epinephrineEpinephrine .3 mg/.3mLInjectionSubcutaneousAsclemed USA, Inc.76420-834
epinephrineEpinephrine .15 mg/.15mLInjectionSubcutaneousAsclemed USA, Inc.76420-835
epinephrineEpinephrine .15 mg/.15mLInjectionSubcutaneousREMEDYREPACK INC.70518-4573
Epinephrine Pediatricsepinephrine 0.15 pediatricsEpinephrine .15 mg/.15mLInjectionSubcutaneousSina Health Inc70385-2038
epinephrineEpinephrine .15 mg/.15mLInjectionSubcutaneousAmneal Pharmaceuticals of New York LLC0115-1695
Epinephrine 0.3 AdultsEpinephrine .3 mg/.3mLInjectionSubcutaneousSina Health Inc70385-2022
EpinephrineEpinephrine .3 mg/.3mLInjectionSubcutaneousAdvanced Rx Pharmacy of Tennessee, LLC80425-0264
epinephrineEpinephrine .3 mg/.3mLInjectionSubcutaneousREMEDYREPACK INC.70518-2048
epinephrineEpinephrine .3 mg/.3mLInjectionSubcutaneousA-S Medication Solutions50090-3155
epinephrineEpinephrine .3 mg/.3mLInjectionSubcutaneousSportpharm LLC85766-061
epinephrineEpinephrine .3 mg/.3mLInjectionSubcutaneousASCLEMED USA INC.76420-467

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