NDC codes

FDA NDC Directory
Product NDC (as listed)68382-180Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68382-0180Add 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
68382-180-0168382018001100 TABLET in 1 BOTTLE (68382-180-01)Marketed from May 3, 2014
68382-180-0568382018005500 TABLET in 1 BOTTLE (68382-180-05)Marketed from May 3, 2014
68382-180-10683820180101000 TABLET in 1 BOTTLE (68382-180-10)Marketed from May 3, 2014
68382-180-7768382018077100 BLISTER PACK in 1 CARTON (68382-180-77) / 1 TABLET in 1 BLISTER PACK (68382-180-30)Marketed from May 3, 2014

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 — 5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078888
Marketing start
Listing expires
Identifiers
Product ID 68382-180_8692aee8-7eb4-4cbb-8a31-3ecc49660195SPL ID 8692aee8-7eb4-4cbb-8a31-3ecc49660195SPL set ID 14fd7c1c-778e-46d4-9024-89b319f15f39RxCUI 866018, 866083, 866090, 866094, 866111UNII 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

N468382018001 followed by a unit qualifier and the quantity

Package 68382-0180-01. 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 .

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 68382-180

What is NDC 68382-180?
68382-180 is the product NDC for Buspirone hydrochloride, Buspirone hydrochloride 5 mg/1 tablet, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 4 package NDCs, 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?
Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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?
259 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/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 2.5 mg/1TabletOralIPG Pharmaceuticals, Inc71085-09371085-0093-60
Buspirone HydrochlorideBuspirone hydrochloride 12.5 mg/1TabletOralIPG Pharmaceuticals, Inc71085-09471085-0094-30
Buspirone HydrochlorideBuspirone hydrochloride 5 mg/1TabletOralCoupler LLC67046-064567046-0645-03
Buspirone HydrochlorideBuspirone hydrochloride 5 mg/1TabletOralREMEDYREPACK INC.70518-458670518-4586-00

All 260 Buspirone hydrochloride NDCs

Other NDCs under ANDA 078888

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

FDA NDC Directory listings under ANDA 078888
ProductStrengthForm · routeLabelerProduct NDC
Buspirone hydrochlorideBuspirone hydrochloride 15 mg/1TabletOralMajor Pharmaceuticals0904-6899
Buspirone hydrochlorideBuspirone hydrochloride 15 mg/1TabletOralAvPAK50268-135
Buspirone hydrochlorideBuspirone hydrochloride 15 mg/1TabletOralCardinal Health 107, LLC55154-3364
Buspirone hydrochlorideBuspirone hydrochloride 7.5 mg/1TabletOralAmerican Health Packaging60687-801
Buspirone hydrochlorideBuspirone hydrochloride 10 mg/1TabletOralAmerican Health Packaging60687-812
Buspirone hydrochlorideBuspirone hydrochloride 15 mg/1TabletOralAmerican Health Packaging60687-823
buspirone hydrochlorideBuspirone hydrochloride 5 mg/1TabletOralZydus Lifesciences Limited65841-781
buspirone hydrochlorideBuspirone hydrochloride 10 mg/1TabletOralZydus Lifesciences Limited65841-782
buspirone hydrochlorideBuspirone hydrochloride 15 mg/1TabletOralZydus Lifesciences Limited65841-783
buspirone hydrochlorideBuspirone hydrochloride 30 mg/1TabletOralZydus Lifesciences Limited65841-784
buspirone hydrochlorideBuspirone hydrochloride 7.5 mg/1TabletOralZydus Lifesciences Limited65841-842
Buspirone hydrochlorideBuspirone hydrochloride 7.5 mg/1TabletOralCoupler LLC67046-1352
Buspirone hydrochlorideBuspirone hydrochloride 10 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-181
Buspirone hydrochlorideBuspirone hydrochloride 15 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-182
Buspirone hydrochlorideBuspirone hydrochloride 30 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-183
Buspirone hydrochlorideBuspirone hydrochloride 7.5 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-623
Buspirone hydrochlorideBuspirone hydrochloride 15 mg/1TabletOralREMEDYREPACK INC.70518-0380
Buspirone hydrochlorideBuspirone hydrochloride 7.5 mg/1TabletOralREMEDYREPACK INC.70518-3906
Buspirone hydrochlorideBuspirone hydrochloride 10 mg/1TabletOralBryant Ranch Prepack71335-0222
Buspirone hydrochlorideBuspirone hydrochloride 7.5 mg/1TabletOralBryant Ranch Prepack71335-2237

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