NDC 71610-714

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-714Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0714Add 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
71610-714-30	71610071430	30 TABLET in 1 BOTTLE (71610-714-30)Marketed from Jun 12, 2023
71610-714-53	71610071453	60 TABLET in 1 BOTTLE (71610-714-53)Marketed from Jun 12, 2023
71610-714-60	71610071460	90 TABLET in 1 BOTTLE (71610-714-60)Marketed from Jun 12, 2023
71610-714-70	71610071470	120 TABLET in 1 BOTTLE (71610-714-70)Marketed from Jun 12, 2023
71610-714-80	71610071480	180 TABLET in 1 BOTTLE (71610-714-80)Marketed from Jun 12, 2023
71610-714-90	71610071490	240 TABLET in 1 BOTTLE (71610-714-90)Marketed from Jun 12, 2023

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): Diphenoxylate Hydrochloride and Atropine Sulfate
Generic name (nonproprietary): diphenoxylate hydrochloride and atropine sulfate
Active ingredients: Diphenoxylate hydrochloride — 2.5 mg/1Atropine sulfate — .025 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213335
Marketing start: Oct 30, 2020
Listing expires: Dec 31, 2026
DEA schedule: CV
Other FDA classes: Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 71610-714_d2906ede-d6cd-449f-83ac-a087b2cec958SPL ID d2906ede-d6cd-449f-83ac-a087b2cec958SPL set ID c11574c7-8344-4987-85ef-f2404daa0885RxCUI 1190572UNII W24OD7YW48, 03J5ZE7KA5
Pharmacologic class: Anticholinergic; Antidiarrheal; Cholinergic Muscarinic Antagonist

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

N471610071430 followed by a unit qualifier and the quantity

Package 71610-0714-30. 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 Jun 13, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Diphenoxylate hydrochloride and atropine sulfate tablets are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213335

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

FDA NDC Directory listings under ANDA 213335
Product	Strength	Form · route	Labeler	Product NDC
Diphenoxylate Hydrochloride and Atropine Sulfate	Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1	TabletOral	SpecGx LLC	0406-1236
Diphenoxylate Hydrochloride and Atropine Sulfate	Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1	TabletOral	American Health Packaging	60687-890

Diphenoxylate Hydrochloride and Atropine Sulfate NDC 71610-714