What is NDC 75826-127?

75826-127 is the product NDC for Phenohytro, Phenobarbital 16.2 mg/5mL + 3 more ingredients elixir, listed with the FDA by Winder Laboratories LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Phenohytro (Phenobarbital, Hyoscyamine Sulfate, Atropine sulfate, and Scopolamine Hydrobromide).

What is the active ingredient?

Phenobarbital, Hyoscyamine sulfate, Atropine sulfate, Scopolamine hydrobromide.

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 Phenohytro?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Phenohytro NDC 75826-127 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)75826-127Labeler and product segments. Claims need a package NDC.

Product NDC at billing width75826-0127Add 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	Copy
75826-127-04	7582601270475826012704	118 mL in 1 BOTTLE, PLASTIC (75826-127-04)Marketed from Jun 25, 2018
75826-127-16	7582601271675826012716	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 LLCNDC labeler code 75826
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Jun 25, 2018
Listing expires: Dec 31, 2026
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 F2R8V82B84, YQE403BP4D, 451IFR0GXB, 03J5ZE7KA5
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

N475826012704 followed by a unit qualifier and the quantity

Package 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 Oct 4, 2019.

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.

Full label on DailyMed (opens in a new tab)

About NDC 75826-127

What is NDC 75826-127?: 75826-127 is the product NDC for Phenohytro, Phenobarbital 16.2 mg/5mL + 3 more ingredients elixir, listed with the FDA by Winder Laboratories LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Phenohytro (Phenobarbital, Hyoscyamine Sulfate, Atropine sulfate, and Scopolamine Hydrobromide).
What is the active ingredient?: Phenobarbital, Hyoscyamine sulfate, Atropine sulfate, Scopolamine hydrobromide.
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 Phenohytro?: 3 other product NDCs are listed under this name. See all Phenohytro NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Phenohytro NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Phenohytrophenobarbital, hyoscyamine sulfate, atropine sulfate, and scopolamine hydrobromide	Phenobarbital 16.2 mg/5mL + 3 more ingredients	ElixirOral	ATLANTIC BIOLOGICALS CORP.	17856-0125	17856-0125-0117856-0125-0217856-0125-05
Phenohytrophenobarbital, hyoscyamine sulfate, atropine sulfate, and scopolamine hydrobromide	Phenobarbital 16.2 mg/5mL + 3 more ingredients	ElixirOral	Winder Laboratories LLC	75826-128	75826-0128-0475826-0128-16
Phenohytrophenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide	Phenobarbital 16.2 mg/1 + 3 more ingredients	TabletOral	Winder Laboratories, LLC	75826-118	75826-0118-0075826-0118-10