Prescription drug · ANDA
Diphenoxylate Hydrochloride and Atropine Sulfate NDC 76385-107
Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 · Tablet · Oral · Unichem Pharmaceuticals (USA), Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76385-107-01 | 7638501070176385010701 | 100 TABLET in 1 BOTTLE (76385-107-01)Marketed from May 15, 2019 | |
| 76385-107-10 | 7638501071076385010710 | 1000 TABLET in 1 BOTTLE (76385-107-10)Marketed from May 15, 2019 |
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
- Unichem Pharmaceuticals (USA), Inc.NDC labeler code 76385
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210819
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 76385-107_606720c6-e55e-4338-b18a-1e1b5018ab7dSPL ID 606720c6-e55e-4338-b18a-1e1b5018ab7dSPL set ID 5117f26c-488f-4ba6-b115-22baf12557f3RxCUI 1190572UNII W24OD7YW48, 03J5ZE7KA5UPC 0376385107017
- 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
N476385010701followed by a unit qualifier and the quantityPackage 76385-0107-01. 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 .
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.
About NDC 76385-107
- What is NDC 76385-107?
- 76385-107 is the product NDC for Diphenoxylate Hydrochloride and Atropine Sulfate, Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 tablet, listed with the FDA by Unichem Pharmaceuticals (USA), Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diphenoxylate Hydrochloride and Atropine Sulfate.
- What is the active ingredient?
- Diphenoxylate hydrochloride, Atropine sulfate.
- Who is the labeler?
- Unichem Pharmaceuticals (USA), Inc., NDC labeler code 76385. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Diphenoxylate Hydrochloride and Atropine Sulfate?
- 26 other product NDCs are listed under this name. See all Diphenoxylate Hydrochloride and Atropine Sulfate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diphenoxylate Hydrochloride and Atropine Sulfate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | American Health Packaging | 60687-890 | 60687-0890-01 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3915 | 70518-3915-01 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | Winder Laboratories LLC | 75826-107 | 75826-0107-0075826-0107-0375826-0107-11+2 more |
| Diphenoxylate Hydrochloride And Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | Direct Rx | 72189-336 | 72189-0336-1072189-0336-30 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8090 | 68788-8090-02 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | SpecGx LLC | 0406-1236 | 00406-1236-0100406-1236-10 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-714 | 71610-0714-3071610-0714-5371610-0714-60+3 more |
| Diphenoxylate hydrochloride and atropine sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | Chartwell RX, LLC | 62135-618 | 62135-0618-12 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | A-S Medication Solutions | 50090-5589 | 50090-5589-0050090-5589-0150090-5589-02 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | A-S Medication Solutions | 50090-5592 | 50090-5592-00 |
All 27 Diphenoxylate Hydrochloride and Atropine Sulfate NDCs