What is NDC 16477-738?

16477-738 is the product NDC for Hyoscyamine Sulfate, Hyoscyamine sulfate .375 mg/1 tablet, extended release, listed with the FDA by Laser Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Laser Pharmaceuticals, LLC, NDC labeler code 16477. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Hyoscyamine Sulfate?

28 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Hyoscyamine Sulfate NDC 16477-738 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)16477-738Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16477-0738Add 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
16477-738-01	1647707380116477073801	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16477-738-01)Marketed from Jan 26, 2024

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): Hyoscyamine Sulfate
Generic name (nonproprietary): hyoscyamine sulfate
Active ingredients: Hyoscyamine sulfate — .375 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Laser Pharmaceuticals, LLCNDC labeler code 16477
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Jan 26, 2024
Listing expires: Dec 31, 2026
Identifiers: Product ID 16477-738_415c6bd6-14f7-8049-e063-6294a90a2f5fSPL ID 415c6bd6-14f7-8049-e063-6294a90a2f5fSPL set ID b12f856f-7157-4aee-bf73-1fdcb4834ffcRxCUI 1046770UNII F2R8V82B84UPC 0316477738019

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

N416477073801 followed by a unit qualifier and the quantity

Package 16477-0738-01. 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 Oct 17, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE This product may be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries and diverticulitis. It can also be used to control gastric secretion, visceral spasm and hypermotility in cystitis, pylorospasm and associated abdominal cramps. Along with appropriate analgesics, this product is indicated in symptomatic relief of biliary and renal colic and as a drying agent in the relief of symptoms of acute rhinitis. This product is effective as adjunctive therapy in the treatment of peptic ulcer and irritable bowel syndrome, acute enterocolitis and other functional gastrointestinal disorders.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16477-738

What is NDC 16477-738?: 16477-738 is the product NDC for Hyoscyamine Sulfate, Hyoscyamine sulfate .375 mg/1 tablet, extended release, listed with the FDA by Laser Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Hyoscyamine Sulfate.
What is the active ingredient?: Hyoscyamine sulfate.
Who is the labeler?: Laser Pharmaceuticals, LLC, NDC labeler code 16477. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Hyoscyamine Sulfate?: 28 other product NDCs are listed under this name. See all Hyoscyamine Sulfate 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 Hyoscyamine Sulfate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Hyoscyamine Sulfate	Hyoscyamine sulfate .125 mg/1	TabletOral	Granulation Technology, Inc.	63561-0203	63561-0203-01
Hyoscyamine Sulfate	Hyoscyamine sulfate .125 mg/1	Tablet, Orally disintegratingOral	Granulation Technology, Inc.	63561-0197	63561-0197-01
Hyoscyamine Sulfate	Hyoscyamine sulfate .125 mg/1	Tablet, Orally disintegratingOral	PD-Rx Pharmaceuticals, Inc.	72789-563	72789-0563-01
Hyoscyamine Sulfate	Hyoscyamine sulfate .125 mg/1	TabletSublingual	Granulation Technology, Inc.	63561-0202	63561-0202-01
Hyoscyamine Sulfate	Hyoscyamine sulfate .125 mg/1	TabletOral	REMEDYREPACK INC.	70518-4436	70518-4436-00
Hyoscyamine Sulfate	Hyoscyamine sulfate .125 mg/1	TabletOral	Westminster Pharmaceuticals, LLC	69367-677	69367-0677-01
Hyoscyamine Sulfate	Hyoscyamine sulfate .125 mg/1	TabletOral	Proficient Rx LP	82804-965	82804-0965-3082804-0965-6082804-0965-64+3 more
Hyoscyamine sulfate	Hyoscyamine sulfate .125 mg/1	Tablet, Orally disintegratingOral	Chartwell RX, LLC	62135-858	62135-0858-12
Hyoscyamine Sulfate	Hyoscyamine sulfate .375 mg/1	Tablet, Extended releaseOral	Patrin Pharma, Inc.	39328-052	39328-0052-10
Hyoscyamine Sulfate	Hyoscyamine sulfate .125 mg/1	Tablet, Orally disintegratingOral	Patrin Pharma, Inc.	39328-049	39328-0049-10

All 29 Hyoscyamine Sulfate NDCs