What is NDC 45146-120?

45146-120 is the product NDC for Orabloc, Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 5 ug/mL injection, listed with the FDA by Pierrel S.p.A.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Orabloc (Articaine hydrochloride and epinephrine bitartrate).

What is the active ingredient?

Articaine hydrochloride, Epinephrine bitartrate.

Pierrel S.p.A., NDC labeler code 45146. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Orabloc?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Orabloc NDC 45146-120 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)45146-120Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45146-0120Add 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 NDC	11-digit (billing)	Package	Copy
45146-120-01	4514601200145146012001	100 CARTRIDGE in 1 BOX (45146-120-01) / 1.8 mL in 1 CARTRIDGEMarketed from Mar 1, 2011
45146-120-02	4514601200245146012002	50 CARTRIDGE in 1 BOX (45146-120-02) / 1.8 mL in 1 CARTRIDGEMarketed from Mar 1, 2011

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Orabloc
Generic name (nonproprietary): articaine hydrochloride and epinephrine bitartrate
Active ingredients: Articaine hydrochloride — 40 mg/mLEpinephrine bitartrate — 5 ug/mL
Dosage form: Injection
Route: Submucosal
Labeler: Pierrel S.p.A.NDC labeler code 45146
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022466
Marketing start: Mar 1, 2011
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Amides (Chemical structure)Catecholamines (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers: Product ID 45146-120_df09bf36-46b3-4edf-9a11-9d12bb7e12b3SPL ID df09bf36-46b3-4edf-9a11-9d12bb7e12b3SPL set ID d18424f0-a691-11dd-ad8b-0800200c9a66RxCUI 1091068, 1091072, 1658966, 1661483UNII 30Q7KI53AK, QS9014Q792
Pharmacologic class: Amide Local Anesthetic; 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 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.

NDC on a medical claim

N445146012001 followed by a unit qualifier and the quantity

Package 45146-0120-01. 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 Nov 22, 2018.

Indications (excerpt from the label)

ORABLOC is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age and older. ORABLOC is a combination of articaine HCl, an amide local anesthetic, and epinephrine, a vasoconstrictor, indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age and older ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 45146-120

What is NDC 45146-120?: 45146-120 is the product NDC for Orabloc, Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 5 ug/mL injection, listed with the FDA by Pierrel S.p.A.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Orabloc (Articaine hydrochloride and epinephrine bitartrate).
What is the active ingredient?: Articaine hydrochloride, Epinephrine bitartrate.
Who is the labeler?: Pierrel S.p.A., NDC labeler code 45146. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Orabloc?: 3 other product NDCs are listed under this name. See all Orabloc 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 Orabloc NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Orablocarticaine hydrochloride and epinephrine bitartrate	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 10 ug/mL	InjectionSubmucosal	Aira LLC	87566-110	87566-0110-0187566-0110-02
Orablocarticaine hydrochloride and epinephrine bitartrate	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 5 ug/mL	InjectionSubmucosal	Aira LLC	87566-120	87566-0120-0187566-0120-02
Orablocarticaine hydrochloride and epinephrine bitartrate	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 10 ug/mL	InjectionSubmucosal	Pierrel S.p.A.	45146-110	45146-0110-0145146-0110-02

Other NDCs under NDA 022466

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

FDA NDC Directory listings under NDA 022466
Product	Strength	Form · route	Labeler	Product NDC
Articaine HCl and Epinephrinearticaine hydrochloride and epinephrine bitartrate	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 10 ug/mL	InjectionSubmucosal	Safco Dental Supply Co.	67239-0209
Articaine HCl and Epinephrinearticaine hydrochloride and epinephrine bitartrate	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 5 ug/mL	InjectionSubmucosal	Safco Dental Supply Co.	67239-0210
Articaine Hydrochloride and Epinephrinearticaine hydrochloride, epinephrine bitartrate	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 10 ug/mL	Injection, SolutionSubmucosal	Burkhart Dental Supply Co., Inc	43498-816
Articaine Hydrochloride and Epinephrinearticaine hydrochloride, epinephrine bitartrate	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 5 ug/mL	Injection, SolutionSubmucosal	Burkhart Dental Supply Co., Inc	43498-993
Orablocarticaine hydrochloride and epinephrine bitartrate	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 10 ug/mL	InjectionSubmucosal	Pierrel S.p.A.	45146-110
Orablocarticaine hydrochloride and epinephrine bitartrate	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 10 ug/mL	InjectionSubmucosal	Aira LLC	87566-110
Orablocarticaine hydrochloride and epinephrine bitartrate	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 5 ug/mL	InjectionSubmucosal	Aira LLC	87566-120