Bupropion Hydrochloride NDC 70010-127

NDC codes

FDA NDC Directory

Product NDC (as listed)70010-127Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70010-0127Add 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
70010-127-03	70010012703	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-127-03)Marketed from Mar 31, 2025
70010-127-05	70010012705	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-127-05)Marketed from Mar 31, 2025
70010-127-06	70010012706	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-127-06)Marketed from Mar 31, 2025

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): Bupropion Hydrochloride
Generic name (nonproprietary): bupropion hydrochloride
Active ingredients: Bupropion hydrochloride — 200 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Granules Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218385
Marketing start: Mar 31, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Dopamine Uptake Inhibitors (Mechanism)Increased Dopamine Activity (Physiologic effect)Increased Norepinephrine Activity (Physiologic effect)Norepinephrine Uptake Inhibitors (Mechanism)
Identifiers: Product ID 70010-127_4377481d-43ac-f347-e063-6394a90acc90SPL ID 4377481d-43ac-f347-e063-6394a90acc90SPL set ID 61e9cbe3-8211-42f3-b68f-581f56651919RxCUI 993503, 993518, 993536UNII ZG7E5POY8OUPC 0370010125032, 0370010126039, 0370010127036
Pharmacologic class: Aminoketone

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

N470010012703 followed by a unit qualifier and the quantity

Package 70010-0127-03. 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 13, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14) ]. The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14) ]. Bupropion Hydrochloride extended-release ta…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 218385

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

FDA NDC Directory listings under ANDA 218385
Product	Strength	Form · route	Labeler	Product NDC
Bupropion Hydrochloride	Bupropion hydrochloride 100 mg/1	Tablet, Film coated, Extended releaseOral	Granules Pharmaceuticals Inc.	70010-125
Bupropion Hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	Granules Pharmaceuticals Inc.	70010-126