Prescription drug · UNAPPROVED DRUG OTHER
Phenohytro NDC 75826-118
phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide · Phenobarbital 16.2 mg/1 + 3 more ingredients · Tablet · Oral · Winder Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75826-118-00 | 75826011800 | 1000 TABLET in 1 BOTTLE, PLASTIC (75826-118-00)Marketed from Feb 29, 2016 | |
| 75826-118-10 | 75826011810 | 100 TABLET in 1 BOTTLE, PLASTIC (75826-118-10)Marketed from Feb 29, 2016 |
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)
- Phenohytro
- Generic name (nonproprietary)
- phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
- Active ingredients
- Phenobarbital — 16.2 mg/1Hyoscyamine sulfate — .1037 mg/1Atropine sulfate — .0194 mg/1Scopolamine hydrobromide — .0065 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Winder Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 75826-118_2b37a6e2-6e67-1233-e063-6294a90a26adSPL ID 2b37a6e2-6e67-1233-e063-6294a90a26adSPL set ID 27c8baac-f8ce-46d8-8a0f-ff769dd408d9RxCUI 1046815, 1739887UNII YQE403BP4D, F2R8V82B84, 03J5ZE7KA5, 451IFR0GXBUPC 0375826118100
- Pharmacologic class
- Anticholinergic; 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
N475826011800followed by a unit qualifier and the quantityPackage 75826-0118-00. 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 Based on a review of this drug by the National Academy of Sciences–National Research Council and/or other information, FDA has classified the indications as follows: “Possibly” effective: For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. May also be useful as adjunctive therapy in the treatment of duodenal ulcer. Final classification of the less-than-effective indications requires further investigation. IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICAT…
Excerpt only. Read the full label for complete information.