Prescription drug · UNAPPROVED DRUG OTHER
Phenohytro NDC 75826-127
Phenobarbital 16.2 mg/5mL + 3 more ingredients · Elixir · Oral · Winder Laboratories LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75826-127-04 | 75826012704 | 118 mL in 1 BOTTLE, PLASTIC (75826-127-04)Marketed from Jun 25, 2018 | |
| 75826-127-16 | 75826012716 | 473 mL in 1 BOTTLE, PLASTIC (75826-127-16)Marketed from Jun 25, 2018 |
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, and scopolamine hydrobromide
- Active ingredients
- Phenobarbital — 16.2 mg/5mLHyoscyamine sulfate — .1037 mg/5mLAtropine sulfate — .0194 mg/5mLScopolamine hydrobromide — .0065 mg/5mL
- Dosage form
- Elixir
- 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 75826-127_2b37aeea-56b7-fb21-e063-6294a90ad79bSPL ID 2b37aeea-56b7-fb21-e063-6294a90ad79bSPL set ID 29be31ef-108e-4b45-9ecc-b6d671da2826RxCUI 1046787, 2048017UNII 03J5ZE7KA5, 451IFR0GXB, F2R8V82B84, YQE403BP4D
- 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
N475826012704followed by a unit qualifier and the quantityPackage 75826-0127-04. 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 the National Academy of Sciences-National Research Council's review of this drug and/or other information, FDA has classified the following indications as "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. 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 COMPLICATIONS.
Excerpt only. Read the full label for complete information.