NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0037Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0037Add 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
80425-0037-1804250037018042500370130 CAPSULE in 1 BOTTLE (80425-0037-1)Marketed from Mar 16, 2016
80425-0037-2804250037028042500370260 CAPSULE in 1 BOTTLE (80425-0037-2)Marketed from Mar 16, 2016

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 200 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204590
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 80425-0037_2a987a87-35f3-e046-e063-6294a90aa7c9SPL ID 2a987a87-35f3-e046-e063-6294a90aa7c9SPL set ID af73fea0-5cd1-0fa2-e053-2a95a90af8fcRxCUI 205323UNII 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

N480425003701 followed by a unit qualifier and the quantity

Package 80425-0037-01. 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)

1. Indications and Usage Section 1 INDICATIONS AND USAGE Celecoxib capsules are indicated 1.1 Osteoarthritis For the management of the signs and symptoms of OA [see Clinical Studies (14.1)] 1.2 Rheumatoid Arthritis For the management of the signs and symptoms of RA [see Clinical Studies (14.2)] 1.3 Juvenile Rheumatoid Arthritis For the management of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)] 1.4 Ankylosing Spondylitis For the management of the signs and symptoms of AS [see Clinical Studies (14.4)] 1.5 Acute Pain For the management of acute pain in adults [see Clinical Studies (14.5)] 1.6 Primary Dysmenorrhea For the management of primary dysmeno…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0037

What is NDC 80425-0037?
80425-0037 is the product NDC for Celecoxib, Celecoxib 200 mg/1 capsule, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 2 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?
Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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?
230 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 200 mg/1CapsuleOralDirect_Rx72189-69572189-0695-3072189-0695-60
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 Pharmacy60760-95860760-0958-1560760-0958-3060760-0958-60
CelecoxibCelecoxib 100 mg/1CapsuleOralCardinal Health 107, LLC55154-016055154-0160-00
CelecoxibCelecoxib 400 mg/1CapsuleOralREMEDYREPACK INC.70518-461970518-4619-00
CelecoxibCelecoxib 100 mg/1CapsuleOralMajor Pharmaceuticals0904-755000904-7550-61
CelecoxibCelecoxib 200 mg/1CapsuleOralMajor Pharmaceuticals0904-755100904-7551-61
CelecoxibCelecoxib 100 mg/1CapsuleOralAvet Pharmaceuticals Inc.23155-96423155-0964-0123155-0964-05

All 231 Celecoxib NDCs

Other NDCs under ANDA 204590

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

FDA NDC Directory listings under ANDA 204590
ProductStrengthForm · routeLabelerProduct NDC
celecoxibCelecoxib 100 mg/1CapsuleOralAsclemed USA, Inc.76420-243
celecoxibCelecoxib 200 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.43063-967
celecoxibCelecoxib 50 mg/1CapsuleOralHAWAII REPACK, INC.85534-0059
celecoxibCelecoxib 400 mg/1CapsuleOralHAWAII REPACK, INC.85534-0060
celecoxibCelecoxib 200 mg/1CapsuleOralHAWAII REPACK, INC.85534-0065
celecoxibCelecoxib 200 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-4392
CelecoxibCelecoxib 100 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0167
celecoxibCelecoxib 200 mg/1CapsuleOralBryant Ranch Prepack71335-0868
celecoxibCelecoxib 200 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-7264
celecoxibCelecoxib 100 mg/1CapsuleOralPreferred Pharmaceuticals, Inc.68788-7286
celecoxibCelecoxib 400 mg/1CapsuleOralSportpharm LLC85766-030
celecoxibCelecoxib 100 mg/1CapsuleOralBryant Ranch Prepack71335-0936
celecoxibCelecoxib 200 mg/1CapsuleOralProficient Rx LP71205-027
celecoxibCelecoxib 200 mg/1CapsuleOralAsclemed USA, Inc.76420-009
CelecoxibCelecoxib 100 mg/1CapsuleOralDirect Rx72189-123
celecoxibCelecoxib 200 mg/1CapsuleOralBryant Ranch Prepack72162-2489
celecoxibCelecoxib 200 mg/1CapsuleOralNorthwind Health Company, LLC51655-253
CelecoxibCelecoxib 100 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0323
celecoxibCelecoxib 100 mg/1CapsuleOralProficient Rx LP71205-439
celecoxibCelecoxib 200 mg/1CapsuleOralRedPharm Drug, Inc.67296-1399

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