NDC codes

FDA NDC Directory
Product NDC (as listed)51079-994Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51079-0994Add 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 NDC11-digit (billing)PackageCopy
51079-994-205107909942051079099420100 BLISTER PACK in 1 CARTON (51079-994-20) / 1 TABLET in 1 BLISTER PACK (51079-994-01)Marketed from Dec 1, 2002

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)
Buspirone Hydrochloride
Generic name (nonproprietary)
buspirone hydrochloride
Active ingredients
Buspirone hydrochloride — 30 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Mylan Institutional Inc.NDC labeler code 51079
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076008
Marketing start
Listing expires
Identifiers
Product ID 51079-994_3a3995cf-40e7-1867-e063-6294a90aa483SPL ID 3a3995cf-40e7-1867-e063-6294a90aa483SPL set ID 91bb5fc9-5121-43c2-b2af-149240d4189aRxCUI 866018, 866083, 866090, 866094UNII 207LT9J9OC

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

N451079099420 followed by a unit qualifier and the quantity

Package 51079-0994-20. 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 .

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 51079-994

What is NDC 51079-994?
51079-994 is the product NDC for Buspirone Hydrochloride, Buspirone hydrochloride 30 mg/1 tablet, listed with the FDA by Mylan Institutional 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 Institutional Inc., NDC labeler code 51079. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Buspirone hydrochlorideBuspirone hydrochloride 5 mg/1TabletOralAmerican Health Packaging60687-98860687-0988-01
Buspirone HydrochlorideBuspirone hydrochloride 5 mg/1TabletOralCardinal Health 107, LLC55154-028555154-0285-00
Buspirone HydrochlorideBuspirone hydrochloride 10 mg/1TabletOralCardinal Health 107, LLC55154-028655154-0286-00
Buspirone HydrochlorideBuspirone hydrochloride 10 mg/1TabletOralUnit Dose Solutions, Inc.87441-01887441-0018-01
Buspirone hydrochlorideBuspirone hydrochloride 15 mg/1TabletOralUnit Dose Solutions, Inc.87441-01987441-0019-01
Buspirone HydrochlorideBuspirone hydrochloride 5 mg/1TabletOralUnit Dose Solutions, Inc.87441-02087441-0020-01
Buspirone hydrochlorideBuspirone hydrochloride 7.5 mg/1TabletOralCoupler LLC67046-135267046-1352-03
Buspirone HydrochlorideBuspirone hydrochloride 12.5 mg/1TabletOralIPG Pharmaceuticals, Inc71085-09471085-0094-30
Buspirone HydrochlorideBuspirone hydrochloride 2.5 mg/1TabletOralIPG Pharmaceuticals, Inc71085-09371085-0093-60
Buspirone HydrochlorideBuspirone hydrochloride 5 mg/1TabletOralCoupler LLC67046-064567046-0645-03

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
ProductStrengthForm · routeLabelerProduct NDC
Buspirone HydrochlorideBuspirone hydrochloride 5 mg/1TabletOralMylan Pharmaceuticals Inc.0378-1140
Buspirone HydrochlorideBuspirone hydrochloride 10 mg/1TabletOralMylan Pharmaceuticals Inc.0378-1150
Buspirone HydrochlorideBuspirone hydrochloride 15 mg/1TabletOralMylan Pharmaceuticals Inc.0378-1165
Buspirone HydrochlorideBuspirone hydrochloride 30 mg/1TabletOralMylan Pharmaceuticals Inc.0378-1175
Buspirone HydrochlorideBuspirone hydrochloride 5 mg/1TabletOralSafecor Health, LLC48433-011
Buspirone HydrochlorideBuspirone hydrochloride 10 mg/1TabletOralSafecor Health, LLC48433-012
Buspirone HydrochlorideBuspirone hydrochloride 15 mg/1TabletOralSafecor Health, LLC48433-013
Buspirone HydrochlorideBuspirone hydrochloride 30 mg/1TabletOralSafecor Health, LLC48433-014
Buspirone HydrochlorideBuspirone hydrochloride 15 mg/1TabletOralMylan Institutional Inc.51079-960
Buspirone HydrochlorideBuspirone hydrochloride 5 mg/1TabletOralMylan Institutional Inc.51079-985
Buspirone HydrochlorideBuspirone hydrochloride 10 mg/1TabletOralMylan Institutional Inc.51079-986
Buspirone HydrochlorideBuspirone hydrochloride 5 mg/1TabletOralCardinal Health 107, LLC55154-0285
Buspirone HydrochlorideBuspirone hydrochloride 10 mg/1TabletOralCardinal Health 107, LLC55154-0286
Buspirone HydrochlorideBuspirone hydrochloride 10 mg/1TabletOralCardinal Health 107, LLC55154-5397
Buspirone HydrochlorideBuspirone hydrochloride 5 mg/1TabletOralCardinal Health 107, LLC55154-5494

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