What is NDC 42794-007?

42794-007 is the product NDC for Protriptyline Hydrochloride, Protriptyline hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Sigmapharm Laboratories, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Sigmapharm Laboratories, LLC, NDC labeler code 42794. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Protriptyline Hydrochloride?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Protriptyline Hydrochloride NDC 42794-007

NDC codes

FDA NDC Directory

Product NDC (as listed)42794-007Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42794-0007Add 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
42794-007-02	42794000702	100 TABLET, FILM COATED in 1 BOTTLE (42794-007-02)Marketed from Mar 2, 2020

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): Protriptyline Hydrochloride
Generic name (nonproprietary): protriptyline hydrochloride
Active ingredients: Protriptyline hydrochloride — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Sigmapharm Laboratories, LLCNDC labeler code 42794
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090462
Marketing start: Mar 2, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 42794-007_f1f190da-554e-55cb-e053-2a95a90a2871SPL ID f1f190da-554e-55cb-e053-2a95a90a2871SPL set ID a023e637-bee9-8c86-e053-2a95a90aa488RxCUI 905168, 905172UNII 44665V00O8UPC 0342794007026, 0342794004025
Pharmacologic class: Tricyclic Antidepressant

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N442794000702 followed by a unit qualifier and the quantity

Package 42794-0007-02. 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 Jan 10, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Protriptyline hydrochloride tablets are indicated for the treatment of symptoms of mental depression in patients who are under close medical supervision. Its activating properties make it particularly suitable for withdrawn and anergic patients.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42794-007

What is NDC 42794-007?: 42794-007 is the product NDC for Protriptyline Hydrochloride, Protriptyline hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Sigmapharm Laboratories, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Protriptyline Hydrochloride.
What is the active ingredient?: Protriptyline hydrochloride.
Who is the labeler?: Sigmapharm Laboratories, LLC, NDC labeler code 42794. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Protriptyline Hydrochloride?: 3 other product NDCs are listed under this name. See all Protriptyline Hydrochloride 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 Protriptyline Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Protriptyline Hydrochloride	Protriptyline hydrochloride 5 mg/1	Tablet, Film coatedOral	Sigmapharm Laboratories, LLC	42794-004	42794-0004-02
Protriptyline Hydrochloride	Protriptyline hydrochloride 5 mg/1	Tablet, Film coatedOral	Epic Pharma, LLC	42806-096	42806-0096-0142806-0096-1042806-0096-30
Protriptyline Hydrochloride	Protriptyline hydrochloride 10 mg/1	Tablet, Film coatedOral	Epic Pharma, LLC	42806-097	42806-0097-0142806-0097-1042806-0097-30

Other NDCs under ANDA 090462

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

FDA NDC Directory listings under ANDA 090462
Product	Strength	Form · route	Labeler	Product NDC
Protriptyline Hydrochloride	Protriptyline hydrochloride 5 mg/1	Tablet, Film coatedOral	Sigmapharm Laboratories, LLC	42794-004