NDC codes

FDA NDC Directory
Product NDC (as listed)63187-633Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0633Add 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
63187-633-30631870633306318706333030 CAPSULE in 1 BOTTLE (63187-633-30)Marketed from Nov 24, 2015
63187-633-60631870633606318706336060 CAPSULE in 1 BOTTLE (63187-633-60)Marketed from Nov 24, 2015
63187-633-90631870633906318706339090 CAPSULE in 1 BOTTLE (63187-633-90)Marketed from Nov 24, 2015

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 200 mg
Generic name (nonproprietary)
celecoxib
Active ingredients
Celecoxib — 200 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 63187
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204519
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 63187-633_a97c2b4d-4a9b-4343-be08-aff7778679ddSPL ID a97c2b4d-4a9b-4343-be08-aff7778679ddSPL set ID feee6a01-63f9-42c3-8bd8-ca713a08b36dRxCUI 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

N463187063330 followed by a unit qualifier and the quantity

Package 63187-0633-30. 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 Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)] Celecoxib is a nonsteroidal anti-inflammatory drug indicated for: • Osteoarthritis (OA) (1.1)R • heumatoid 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) Celecoxib is inCelecoxib is indicated for relief of the signs and symptoms of OA [see …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-633

What is NDC 63187-633?
63187-633 is the product NDC for Celecoxib 200 mg (celecoxib), Celecoxib 200 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Celecoxib 200 mg (Celecoxib).
What is the active ingredient?
Celecoxib.
Who is the labeler?
Proficient Rx LP, NDC labeler code 63187. 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 200 mg?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 204519

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

FDA NDC Directory listings under ANDA 204519
ProductStrengthForm · routeLabelerProduct NDC
CelecoxibCelecoxib 100 mg/1CapsuleOralMajor Pharmaceuticals0904-7550
CelecoxibCelecoxib 200 mg/1CapsuleOralMajor Pharmaceuticals0904-7551
CelecoxibCelecoxib 50 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-267
CelecoxibCelecoxib 100 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-268
CelecoxibCelecoxib 200 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-269
CelecoxibCelecoxib 400 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-270
CelecoxibCelecoxib 100 mg/1CapsuleOralAvPAK50268-168
CelecoxibCelecoxib 200 mg/1CapsuleOralAvPAK50268-169
CelecoxibCelecoxib 100 mg/1CapsuleOralCardinal Health 107, LLC55154-0160
CelecoxibCelecoxib 50 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-140
CelecoxibCelecoxib 100 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-141
CelecoxibCelecoxib 200 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-142
CelecoxibCelecoxib 400 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-143
CelecoxibCelecoxib 200 mg/1CapsuleOralRedPharm Drug67296-1920
CelecoxibCelecoxib 100 mg/1CapsuleOralProficient Rx LP71205-020
CelecoxibCelecoxib 200 mg/1CapsuleOralProficient Rx LP71205-055

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