Prescription drug · ANDA
Diphenoxylate Hydrochloride and Atropine Sulfate NDC 75826-107
Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 · Tablet · Oral · Winder Laboratories LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75826-107-00 | 7582601070075826010700 | 1000 TABLET in 1 BOTTLE, PLASTIC (75826-107-00)Marketed from Sep 1, 2022 | |
| 75826-107-03 | 7582601070375826010703 | 100 TABLET in 1 BOTTLE, PLASTIC (75826-107-03)Marketed from Sep 1, 2022 | |
| 75826-107-11 | 7582601071175826010711 | 10 TABLET in 1 BOTTLE, PLASTIC (75826-107-11)Marketed from Sep 1, 2022 | |
| 75826-107-33 | 7582601073375826010733 | 30 TABLET in 1 BOTTLE, PLASTIC (75826-107-33)Marketed from Sep 1, 2022 | |
| 75826-107-90 | 7582601079075826010790 | 90 TABLET in 1 BOTTLE, PLASTIC (75826-107-90)Marketed from Sep 1, 2022 |
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
- Winder Laboratories LLCNDC labeler code 75826
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211362
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 75826-107_2b0ecbe9-ac10-5211-e063-6394a90a123eSPL ID 2b0ecbe9-ac10-5211-e063-6394a90a123eSPL set ID 7344a2d2-1f8a-4c5a-90e3-181b919c0c7aRxCUI 1190572UNII W24OD7YW48, 03J5ZE7KA5UPC 0375826107036, 0375826107333, 0375826107005, 0375826107906, 0375826107111
- 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
N475826010700followed by a unit qualifier and the quantityPackage 75826-0107-00. 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 is 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 75826-107
- What is NDC 75826-107?
- 75826-107 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 Winder Laboratories LLC. It has 5 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?
- Winder Laboratories LLC, NDC labeler code 75826. 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 | 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 | 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 | 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 | 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 | Redpharm Drug | 67296-2240 | 67296-2240-05 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | Redpharm Drug Inc. | 67296-1485 | 67296-1485-09 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-375 | 72789-0375-25 |
All 27 Diphenoxylate Hydrochloride and Atropine Sulfate NDCs