NDC codes

FDA NDC Directory
Product NDC (as listed)76420-845Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76420-0845Add 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
76420-845-01764200845011 CAPSULE in 1 BOTTLE (76420-845-01)Marketed from Aug 17, 2024
76420-845-0576420084505500 CAPSULE in 1 BOTTLE (76420-845-05)Marketed from Aug 17, 2024
76420-845-07764200845077 CAPSULE in 1 BOTTLE (76420-845-07)Marketed from Aug 17, 2024
76420-845-147642008451414 CAPSULE in 1 BOTTLE (76420-845-14)Marketed from Aug 17, 2024
76420-845-207642008452020 CAPSULE in 1 BOTTLE (76420-845-20)Marketed from Aug 17, 2024
76420-845-307642008453030 CAPSULE in 1 BOTTLE (76420-845-30)Marketed from Aug 17, 2024
76420-845-607642008456060 CAPSULE in 1 BOTTLE (76420-845-60)Marketed from Aug 17, 2024
76420-845-907642008459090 CAPSULE in 1 BOTTLE (76420-845-90)Marketed from Aug 17, 2024

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 — 400 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Asclemed USA, Inc.NDC labeler code 76420
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205129
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 76420-845_327a5fba-3c08-7bba-e063-6294a90a75e5SPL ID 327a5fba-3c08-7bba-e063-6294a90a75e5SPL set ID 5d0dcac1-237c-47aa-bcfb-50fa20b5b838RxCUI 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

N476420084501 followed by a unit qualifier and the quantity

Package 76420-0845-01. 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 Celecoxib is 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-845

What is NDC 76420-845?
76420-845 is the product NDC for Celecoxib, Celecoxib 400 mg/1 capsule, listed with the FDA by Asclemed USA, Inc.. It has 8 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?
Asclemed USA, Inc., NDC labeler code 76420. 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?
228 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 100 mg/1CapsuleOralMajor Pharmaceuticals0904-755000904-7550-61
CelecoxibCelecoxib 200 mg/1CapsuleOralMajor Pharmaceuticals0904-755100904-7551-61
CelecoxibCelecoxib 50 mg/1CapsuleOralAvet Pharmaceuticals Inc.23155-96323155-0963-06
CelecoxibCelecoxib 100 mg/1CapsuleOralAvet Pharmaceuticals Inc.23155-96423155-0964-0123155-0964-05

All 229 Celecoxib NDCs

Other NDCs under ANDA 205129

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

FDA NDC Directory listings under ANDA 205129
ProductStrengthForm · routeLabelerProduct NDC
CelecoxibCelecoxib 200 mg/1CapsuleOralMedsource Pharmaceuticals45865-234
CelecoxibCelecoxib 50 mg/1CapsuleOralScieGen Pharmaceuticals, Inc.50228-156
CelecoxibCelecoxib 100 mg/1CapsuleOralScieGen Pharmaceuticals, Inc.50228-157
CelecoxibCelecoxib 200 mg/1CapsuleOralScieGen Pharmaceuticals, Inc.50228-158
CelecoxibCelecoxib 400 mg/1CapsuleOralScieGen Pharmaceuticals, Inc.50228-159
CelecoxibCelecoxib 100 mg/1CapsuleOralST. MARY'S MEDICAL PARK PHARMACY60760-649
CelecoxibCelecoxib 200 mg/1CapsuleOralSt Mary's Medical Park Pharmacy60760-742
CelecoxibCelecoxib 200 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-2733
CelecoxibCelecoxib 200 mg/1CapsuleOralPreferred Pharmaceuticals, Inc.68788-8197
CelecoxibCelecoxib 100 mg/1CapsuleOralPreferred Pharmaceuticals, Inc.68788-8206
CelecoxibCelecoxib 200 mg/1CapsuleOralREMEDYREPACK INC.70518-3733
CelecoxibCelecoxib 400 mg/1CapsuleOralREMEDYREPACK INC.70518-4619
CelecoxibCelecoxib 200 mg/1CapsuleOralProficient Rx LP71205-664
CelecoxibCelecoxib 200 mg/1CapsuleOralBryant Ranch Prepack71335-2220
CelecoxibCelecoxib 100 mg/1CapsuleOralBryant Ranch Prepack71335-2222
CelecoxibCelecoxib 200 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-584
CelecoxibCelecoxib 200 mg/1CapsuleOralBryant Ranch Prepack72162-2175
CelecoxibCelecoxib 100 mg/1CapsuleOralBryant Ranch Prepack72162-2254
CelecoxibCelecoxib 200 mg/1CapsuleOralDirectRx72189-360
CelecoxibCelecoxib 200 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.72789-259

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