What is NDC 0178-0900?

0178-0900 is the product NDC for Thiola (tiopronin), Tiopronin 100 mg/1 tablet, sugar coated, listed with the FDA by Mission Pharmacal Company. It has 1 package NDC, shown above in 10- and 11-digit form.

Mission Pharmacal Company, NDC labeler code 0178. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Thiola?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Thiola NDC 0178-0900 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0178-0900Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00178-0900Add 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
0178-0900-01	00178090001	100 TABLET, SUGAR COATED in 1 BOTTLE (0178-0900-01)Marketed from Aug 11, 1988

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): Thiola
Generic name (nonproprietary): tiopronin
Active ingredients: Tiopronin — 100 mg/1
Dosage form: Tablet, Sugar coated
Route: Oral
Labeler: Mission Pharmacal CompanyNDC labeler code 0178
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 019569
Marketing start: Aug 11, 1988
Listing expires: Dec 31, 2027
Other FDA classes: Cystine Disulfide Reduction (Mechanism)N-substituted Glycines (Chemical structure)
Identifiers: Product ID 0178-0900_5a09fd4c-1e6d-01db-e063-6394a90a187aSPL ID 5a09fd4c-1e6d-01db-e063-6394a90a187aSPL set ID 494a714e-923c-cd57-df6c-12886afb265aRxCUI 198287, 207840UNII C5W04GO61SUPC 0301780900017
Pharmacologic class: Reducing and Complexing Thiol

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

N400178090001 followed by a unit qualifier and the quantity

Package 00178-0900-01. 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 Aug 27, 2026.

Indications (excerpt from the label)

THIOLA is indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone. --------------------------------------------INDICATIONS AND USAGE----------------------------------------- THIOLA is a reducing and complexing thiol indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone. (1)…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0178-0900

What is NDC 0178-0900?: 0178-0900 is the product NDC for Thiola (tiopronin), Tiopronin 100 mg/1 tablet, sugar coated, listed with the FDA by Mission Pharmacal Company. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Thiola (Tiopronin).
What is the active ingredient?: Tiopronin.
Who is the labeler?: Mission Pharmacal Company, NDC labeler code 0178. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Thiola?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 019569

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 019569
Product	Strength	Form · route	Labeler	Product NDC
Tiopronin	Tiopronin 100 mg/1	Tablet, Sugar coatedOral	BioComp Pharma, Inc.	44523-053

Thiola (Tiopronin) NDC 0178-0900