What is NDC 0378-1175?

0378-1175 is the product NDC for Buspirone Hydrochloride, Buspirone hydrochloride 30 mg/1 tablet, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Buspirone Hydrochloride?

260 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Buspirone Hydrochloride NDC 0378-1175

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-1175Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-1175Add 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
0378-1175-91	0037811759100378117591	60 TABLET in 1 BOTTLE, PLASTIC (0378-1175-91)Marketed from Aug 1, 2001

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): Buspirone Hydrochloride
Generic name (nonproprietary): buspirone hydrochloride
Active ingredients: Buspirone hydrochloride — 30 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076008
Marketing start: Aug 1, 2001
Listing expires: Dec 31, 2027
Identifiers: Product ID 0378-1175_590dcfd9-dcb7-4aa9-8a75-c7f1acbd148fSPL ID 590dcfd9-dcb7-4aa9-8a75-c7f1acbd148fSPL set ID 7c9eafb9-9ce1-4b28-900c-8fcb4b23424eRxCUI 866018, 866083, 866090, 866094UNII 207LT9J9OCUPC 0303781165051, 0303781175913, 0303781150057, 0303781140058

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

N400378117591 followed by a unit qualifier and the quantity

Package 00378-1175-91. 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 Jun 15, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these s…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-1175

What is NDC 0378-1175?: 0378-1175 is the product NDC for Buspirone Hydrochloride, Buspirone hydrochloride 30 mg/1 tablet, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Buspirone Hydrochloride.
What is the active ingredient?: Buspirone hydrochloride.
Who is the labeler?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Buspirone Hydrochloride?: 260 other product NDCs are listed under this name. See all Buspirone Hydrochloride 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 Buspirone Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Buspirone hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	American Health Packaging	60687-988	60687-0988-01
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	Cardinal Health 107, LLC	55154-0285	55154-0285-00
Buspirone Hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	Cardinal Health 107, LLC	55154-0286	55154-0286-00
Buspirone Hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-018	87441-0018-01
Buspirone hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-019	87441-0019-01
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-020	87441-0020-01
Buspirone hydrochloride	Buspirone hydrochloride 7.5 mg/1	TabletOral	Coupler LLC	67046-1352	67046-1352-03
Buspirone Hydrochloride	Buspirone hydrochloride 12.5 mg/1	TabletOral	IPG Pharmaceuticals, Inc	71085-094	71085-0094-30
Buspirone Hydrochloride	Buspirone hydrochloride 2.5 mg/1	TabletOral	IPG Pharmaceuticals, Inc	71085-093	71085-0093-60
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	Coupler LLC	67046-0645	67046-0645-03

All 261 Buspirone Hydrochloride NDCs

Other NDCs under ANDA 076008

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

FDA NDC Directory listings under ANDA 076008
Product	Strength	Form · route	Labeler	Product NDC
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	Cardinal Health 107, LLC	55154-5494
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	Cardinal Health 107, LLC	55154-0285
Buspirone Hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	Cardinal Health 107, LLC	55154-0286
Buspirone Hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	Cardinal Health 107, LLC	55154-5397
Buspirone Hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	Mylan Institutional Inc.	51079-960
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	Mylan Institutional Inc.	51079-985
Buspirone Hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	Mylan Institutional Inc.	51079-986
Buspirone Hydrochloride	Buspirone hydrochloride 30 mg/1	TabletOral	Mylan Institutional Inc.	51079-994
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	Safecor Health, LLC	48433-011
Buspirone Hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	Safecor Health, LLC	48433-012
Buspirone Hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	Safecor Health, LLC	48433-013
Buspirone Hydrochloride	Buspirone hydrochloride 30 mg/1	TabletOral	Safecor Health, LLC	48433-014
Buspirone Hydrochloride	Buspirone hydrochloride 5 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-1140
Buspirone Hydrochloride	Buspirone hydrochloride 10 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-1150
Buspirone Hydrochloride	Buspirone hydrochloride 15 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-1165