What is NDC 0615-8537?

0615-8537 is the product NDC for Hyoscyamine Sulfate, Hyoscyamine sulfate .125 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.

NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 0615-8537 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8537Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8537Add 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
0615-8537-39	0061585373900615853739	30 TABLET in 1 BLISTER PACK (0615-8537-39)Marketed from Sep 10, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — .125 mg/1
Dosage form: Tablet
Route: Oral
Labeler: NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Feb 15, 2024
Listing expires: Dec 31, 2027
Identifiers: Product ID 0615-8537_a3679381-635f-42c7-a31a-711b5a5a3d17SPL ID a3679381-635f-42c7-a31a-711b5a5a3d17SPL set ID e291da2e-a693-43f5-8cdd-2b8725371b79RxCUI 1047905UNII F2R8V82B84

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

N400615853739 followed by a unit qualifier and the quantity

Package 00615-8537-39. 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 Sep 30, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Hyoscyamine Sulfate Tablets USP are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretions, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0615-8537

What is NDC 0615-8537?: 0615-8537 is the product NDC for Hyoscyamine Sulfate, Hyoscyamine sulfate .125 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. 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?: NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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