NDC codes

FDA NDC Directory
Product NDC (as listed)70710-1958Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70710-1958Add 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
70710-1958-770710195807707101958075 BLISTER PACK in 1 CARTON (70710-1958-7) / 6 SUPPOSITORY in 1 BLISTER PACK (70710-1958-6)Marketed from Apr 15, 2024

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)
Indomethacin
Generic name (nonproprietary)
indomethacin
Active ingredients
Indomethacin — 50 mg/1
Dosage form
Suppository
Route
Rectal
Labeler
Zydus Pharmaceuticals USA Inc.NDC labeler code 70710
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216184
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 70710-1958_472b97d6-5eef-4fc5-8a01-b5466d00715eSPL ID 472b97d6-5eef-4fc5-8a01-b5466d00715eSPL set ID 7c911ac4-db70-44bf-8374-01c8260aa3d4RxCUI 197819UNII XXE1CET956

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N470710195807 followed by a unit qualifier and the quantity

Package 70710-1958-07. 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)

Indomethacin suppository is indicated for: Moderate to severe rheumatoid arthritis including acute flares of chronic disease Moderate to severe ankylosing spondylitis Moderate to severe osteoarthritis Acute painful shoulder (bursitis and/or tendinitis) Acute gouty arthritis Indomethacin is a nonsteroidal anti-inflammatory drug indicated for: Moderate to severe rheumatoid arthritis including acute flares of chronic disease Moderate to severe ankylosing spondylitis Moderate to severe osteoarthritis Acute painful shoulder (bursitis and/or tendinitis) Acute gouty arthritis ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70710-1958

What is NDC 70710-1958?
70710-1958 is the product NDC for Indomethacin, Indomethacin 50 mg/1 suppository, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Indomethacin.
What is the active ingredient?
Indomethacin.
Who is the labeler?
Zydus Pharmaceuticals USA Inc., NDC labeler code 70710. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Indomethacin?
79 other product NDCs are listed under this name. See all Indomethacin 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 Indomethacin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
IndomethacinIndomethacin 50 mg/1CapsuleOralCoupler LLC67046-041667046-0416-03
IndomethacinIndomethacin 50 mg/1SuppositoryRectalNorthStar RxLLC72603-28172603-0281-30
IndomethacinIndomethacin 50 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-405568788-4055-03
IndomethacinIndomethacin 50 mg/1SuppositoryRectalCamber Pharmaceuticals, Inc.31722-05131722-0051-31
IndomethacinIndomethacin 50 mg/1SuppositoryRectalAmneal Pharmaceuticals NY LLC69238-208669238-2086-03
IndomethacinIndomethacin 50 mg/1SuppositoryRectalHikma Pharmaceuticals USA Inc.0054-195000054-1950-30
IndomethacinIndomethacin 50 mg/1CapsuleOralSt. Mary's Medical Park Pharmacy60760-91660760-0916-2160760-0916-30
IndomethacinIndomethacin 25 mg/5mLSuspensionOralANI Pharmaceuticals, Inc.70954-63770954-0637-10
IndomethacinIndomethacin 50 mg/1SuppositoryRectalZydus Pharmaceuticals USA Inc.70710-185270710-1852-07
IndomethacinIndomethacin 50 mg/1SuppositoryRectalZydus Lifesciences Limited70771-176670771-1766-07

All 80 Indomethacin NDCs

Other NDCs under ANDA 216184

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

FDA NDC Directory listings under ANDA 216184
ProductStrengthForm · routeLabelerProduct NDC
IndomethacinIndomethacin 50 mg/1SuppositoryRectalZydus Pharmaceuticals USA Inc.70710-1852
IndomethacinIndomethacin 50 mg/1SuppositoryRectalZydus Lifesciences Limited70771-1766

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