NDC codes

FDA NDC Directory
Product NDC (as listed)72789-374Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72789-0374Add 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
72789-374-017278903740172789037401100 TABLET in 1 BOTTLE, PLASTIC (72789-374-01)Marketed from Aug 27, 2024
72789-374-827278903748272789037482500 TABLET in 1 BOTTLE, PLASTIC (72789-374-82)Marketed from Jan 25, 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)
Sulindac
Generic name (nonproprietary)
sulindac
Active ingredients
Sulindac — 200 mg/1
Dosage form
Tablet
Route
Oral
Labeler
PD-Rx Pharmaceuticals, Inc.NDC labeler code 72789
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 072051
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 72789-374_31f654da-06fe-9e86-e063-6294a90a3312SPL ID 31f654da-06fe-9e86-e063-6294a90a3312SPL set ID 1fffe88d-50c8-45cf-ac7c-a62b665c89a8RxCUI 198239UNII 184SNS8VUHUPC 0372789374826

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

N472789037401 followed by a unit qualifier and the quantity

Package 72789-0374-01. 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)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of sulindac tablets and other treatment options before deciding to use sulindac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Sulindac tablets are indicated for acute or long-term use in the relief of signs and symptoms of the following: Osteoarthritis Rheumatoid arthritis* Ankylosing spondylitis Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis) Acute gouty arthritis

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72789-374

What is NDC 72789-374?
72789-374 is the product NDC for Sulindac, Sulindac 200 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Sulindac.
What is the active ingredient?
Sulindac.
Who is the labeler?
PD-Rx Pharmaceuticals, Inc., NDC labeler code 72789. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sulindac?
12 other product NDCs are listed under this name. See all Sulindac 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 Sulindac NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
SulindacSulindac 150 mg/1TabletOralPuraCap Laboratories LLC dba Blu Pharmaceuticals24658-77024658-0770-0124658-0770-05
SulindacSulindac 200 mg/1TabletOralPuraCap Laboratories LLC dba Blu Pharmaceuticals24658-77124658-0771-0124658-0771-05
SulindacSulindac 200 mg/1TabletOralEpic Pharma, LLC42806-01142806-0011-0142806-0011-0542806-0011-10
SulindacSulindac 150 mg/1TabletOralEpic Pharma, LLC42806-01842806-0018-0142806-0018-0542806-0018-10
SulindacSulindac 200 mg/1TabletOralA-S Medication Solutions50090-052950090-0529-04
SulindacSulindac 200 mg/1TabletOralProficient Rx LP71205-64871205-0648-3071205-0648-6071205-0648-90
SulindacSulindac 200 mg/1TabletOralA-S Medication Solutions50090-209350090-2093-04
SulindacSulindac 150 mg/1TabletOralSun Pharmaceutical Industries, Inc.53489-47853489-0478-0153489-0478-0253489-0478-03+3 more
SulindacSulindac 200 mg/1TabletOralSun Pharmaceutical Industries, Inc.53489-47953489-0479-0153489-0479-0253489-0479-03+3 more
SulindacSulindac 150 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-37372789-0373-0172789-0373-82

All 13 Sulindac NDCs

Other NDCs under ANDA 072051

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

FDA NDC Directory listings under ANDA 072051
ProductStrengthForm · routeLabelerProduct NDC
SulindacSulindac 200 mg/1TabletOralA-S Medication Solutions50090-2093
SulindacSulindac 200 mg/1TabletOralSun Pharmaceutical Industries, Inc.53489-479

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