NDC codes

FDA NDC Directory
Product NDC (as listed)0832-0038Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00832-0038Add 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
0832-0038-000083200380000832003800100 TABLET in 1 BOTTLE (0832-0038-00)Marketed from Nov 7, 2011
0832-0038-1000832003810008320038101000 TABLET in 1 BOTTLE (0832-0038-10)Marketed from Nov 7, 2011
0832-0038-500083200385000832003850500 TABLET in 1 BOTTLE (0832-0038-50)Marketed from Nov 7, 2011

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)
Oxybutynin Chloride
Generic name (nonproprietary)
oxybutynin chloride
Active ingredients
Oxybutynin chloride — 5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Upsher-Smith Laboratories, LLCNDC labeler code 0832
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074625
Marketing start
Marketing end
Other FDA classes
Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers
Product ID 0832-0038_45af3420-b44f-39a1-e063-6394a90ad626SPL ID 45af3420-b44f-39a1-e063-6394a90ad626SPL set ID 3ee6835a-7a7d-49a9-8460-2f1dd270ead3RxCUI 863664UNII L9F3D9RENQ
Pharmacologic class
Cholinergic Muscarinic Antagonist

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

N400832003800 followed by a unit qualifier and the quantity

Package 00832-0038-00. 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 Oxybutynin chloride tablets, USP are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0832-0038

What is NDC 0832-0038?
0832-0038 is the product NDC for Oxybutynin Chloride, Oxybutynin chloride 5 mg/1 tablet, listed with the FDA by Upsher-Smith Laboratories, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Oxybutynin Chloride.
What is the active ingredient?
Oxybutynin chloride.
Who is the labeler?
Upsher-Smith Laboratories, LLC, NDC labeler code 0832. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Oxybutynin Chloride?
79 other product NDCs are listed under this name. See all Oxybutynin Chloride 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 Oxybutynin Chloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Oxybutynin ChlorideOxybutynin chloride 2.5 mg/1TabletOralTruPharma LLC52817-26152817-0261-10
Oxybutynin ChlorideOxybutynin chloride 2.5 mg/1TabletOralRISING PHARMA HOLDINGS, INC.64980-73464980-0734-01
Oxybutynin ChlorideOxybutynin chloride 5 mg/1TabletOralCoupler LLC67046-138167046-1381-03
Oxybutynin ChlorideOxybutynin chloride 5 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-91323155-0913-0123155-0913-0523155-0913-10
Oxybutynin ChlorideOxybutynin chloride 5 mg/1TabletOralRISING PHARMA HOLDINGS, INC.64980-67964980-0679-0164980-0679-1064980-0679-50
Oxybutynin ChlorideOxybutynin chloride 5 mg/1TabletOralA-S Medication Solutions50090-807850090-8078-0050090-8078-0150090-8078-03
Oxybutynin ChlorideOxybutynin chloride 5 mg/1TabletOralAmerican Health Packaging60687-89960687-0899-01
Oxybutynin ChlorideOxybutynin chloride 2.5 mg/1TabletOralStrides Pharma Science Limited64380-19064380-0190-01
Oxybutynin ChlorideOxybutynin chloride 15 mg/1Tablet, Extended releaseOralCoupler LLC67046-160067046-1600-03
Oxybutynin ChlorideOxybutynin chloride 5 mg/1Tablet, Extended releaseOralCoupler LLC67046-159967046-1599-03

All 80 Oxybutynin Chloride NDCs

Other NDCs under ANDA 074625

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

FDA NDC Directory listings under ANDA 074625
ProductStrengthForm · routeLabelerProduct NDC
Oxybutynin ChlorideOxybutynin chloride 5 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC43353-978

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