NDC codes

FDA NDC Directory
Product NDC (as listed)65862-908Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0908Add 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
65862-908-0165862090801100 CAPSULE in 1 BOTTLE (65862-908-01)Marketed from Feb 1, 2016
65862-908-0565862090805500 CAPSULE in 1 BOTTLE (65862-908-05)Marketed from Feb 1, 2016
65862-908-99658620908991000 CAPSULE in 1 BOTTLE (65862-908-99)Marketed from Feb 1, 2016

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)
Celecoxib
Generic name (nonproprietary)
celecoxib
Active ingredients
Celecoxib — 100 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 65862
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206827
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 65862-908_5969bc02-84f8-41e5-a6b5-abcb6a985591SPL ID 5969bc02-84f8-41e5-a6b5-abcb6a985591SPL set ID 1e811c3a-5653-4617-b958-380802cc443aRxCUI 205322, 205323, 349514, 686379UNII JCX84Q7J1L

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

N465862090801 followed by a unit qualifier and the quantity

Package 65862-0908-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Celecoxib capsules are indicated Celecoxib is a nonsteroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) (1.1) Rheumatoid Arthritis (RA) (1.2) Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3) Ankylosing Spondylitis (AS) (1.4) Acute Pain (AP) (1.5) Primary Dysmenorrhea (PD) (1.6) 1.1 Osteoarthritis (OA) For the management of the signs and symptoms of OA [see Clinical Studies (14.1) ]. 1.2 Rheumatoid Arthritis (RA) For the management of the signs and symptoms of RA [see Clinical Studies (14.2) ]. 1.3 Juvenile Rheumatoid Arthritis (JRA) For the management of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3) ]. 1.4 Ankyl…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65862-908

What is NDC 65862-908?
65862-908 is the product NDC for Celecoxib, Celecoxib 100 mg/1 capsule, listed with the FDA by Aurobindo Pharma Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Celecoxib.
What is the active ingredient?
Celecoxib.
Who is the labeler?
Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Celecoxib?
229 other product NDCs are listed under this name. See all Celecoxib 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 Celecoxib NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
CelecoxibCelecoxib 100 mg/1CapsuleOralSt. Mary's Medical Park Pharmacy60760-94260760-0942-60
CelecoxibCelecoxib 100 mg/1CapsuleOralDirect_Rx72189-68572189-0685-6072189-0685-72
CelecoxibCelecoxib 200 mg/1CapsuleOralREMEDYREPACK INC.70518-472670518-4726-00
CelecoxibCelecoxib 200 mg/1CapsuleOralSt. Mary's Medical Park Pharmacy60760-95860760-0958-1560760-0958-30
CelecoxibCelecoxib 100 mg/1CapsuleOralCardinal Health 107, LLC55154-016055154-0160-00
CelecoxibCelecoxib 400 mg/1CapsuleOralREMEDYREPACK INC.70518-461970518-4619-00
CelecoxibCelecoxib 200 mg/1CapsuleOralMajor Pharmaceuticals0904-755100904-7551-61
CelecoxibCelecoxib 100 mg/1CapsuleOralMajor Pharmaceuticals0904-755000904-7550-61
CelecoxibCelecoxib 50 mg/1CapsuleOralAvet Pharmaceuticals Inc.23155-96323155-0963-06
CelecoxibCelecoxib 100 mg/1CapsuleOralAvet Pharmaceuticals Inc.23155-96423155-0964-0123155-0964-05

All 230 Celecoxib NDCs

Other NDCs under ANDA 206827

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

FDA NDC Directory listings under ANDA 206827
ProductStrengthForm · routeLabelerProduct NDC
CelecoxibCelecoxib 50 mg/1CapsuleOralAurobindo Pharma Limited65862-907
CelecoxibCelecoxib 200 mg/1CapsuleOralAurobindo Pharma Limited65862-909
CelecoxibCelecoxib 400 mg/1CapsuleOralAurobindo Pharma Limited65862-910
CelecoxibCelecoxib 200 mg/1CapsuleOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8571
CelecoxibCelecoxib 100 mg/1CapsuleOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8572
CelecoxibCelecoxib 200 mg/1CapsuleOralREMEDYREPACK INC.70518-4726

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