NDC codes

FDA NDC Directory
Product NDC (as listed)46708-268Labeler and product segments. Claims need a package NDC.
Product NDC at billing width46708-0268Add 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
46708-268-12467080268124670802681280 CAPSULE in 1 CARTON (46708-268-12)Marketed from Aug 22, 2015
46708-268-30467080268304670802683030 CAPSULE in 1 BOTTLE (46708-268-30)Marketed from Aug 22, 2015
46708-268-314670802683146708026831100 CAPSULE in 1 BOTTLE (46708-268-31)Marketed from Aug 22, 2015
46708-268-60467080268604670802686060 CAPSULE in 1 BOTTLE (46708-268-60)Marketed from Aug 22, 2015
46708-268-714670802687146708026871500 CAPSULE in 1 BOTTLE (46708-268-71)Marketed from Aug 22, 2015
46708-268-9146708026891467080268911000 CAPSULE in 1 BOTTLE (46708-268-91)Marketed from Aug 22, 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
Generic name (nonproprietary)
celecoxib
Active ingredients
Celecoxib — 100 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Alembic Pharmaceuticals LimitedNDC labeler code 46708
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 46708-268_c884ffd4-3a40-48a1-99b6-73b1ef9324b4SPL ID c884ffd4-3a40-48a1-99b6-73b1ef9324b4SPL set ID 14e8d788-e44c-4a40-8678-25cf45fed477RxCUI 205322, 205323, 349514, 686379UNII JCX84Q7J1LUPC 0346708267308, 0346708268305, 0346708269302, 0346708270308

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

N446708026812 followed by a unit qualifier and the quantity

Package 46708-0268-12. 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)

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 non steroidal 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) Celecoxib is indicated for relief of the signs and symptoms of OA [ see Clinical Studies (14.1) ] 1.2 Rheumatoid Arthriti…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-268

What is NDC 46708-268?
46708-268 is the product NDC for Celecoxib, Celecoxib 100 mg/1 capsule, listed with the FDA by Alembic Pharmaceuticals Limited. It has 6 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?
Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 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 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
Celecoxib 200 mgcelecoxibCelecoxib 200 mg/1CapsuleOralProficient Rx LP63187-633

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