Prescription drug · ANDA
Indocin (Indomethacin) NDC 69344-102
Indomethacin 50 mg/1 · Suppository · Rectal · Zyla Life Sciences US Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69344-102-33 | 6934401023369344010233 | 30 SUPPOSITORY in 1 BOX (69344-102-33)Marketed from Aug 31, 1992 |
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)
- Indocin
- Generic name (nonproprietary)
- indomethacin
- Active ingredients
- Indomethacin — 50 mg/1
- Dosage form
- Suppository
- Route
- Rectal
- Labeler
- Zyla Life Sciences US Inc.NDC labeler code 69344
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 073314
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 69344-102_462a8532-9cea-682f-e063-6394a90a50e4SPL ID 462a8532-9cea-682f-e063-6394a90a50e4SPL set ID 3b36645c-de5e-4263-ae06-2f6ff6a9add2RxCUI 197819, 206969UNII XXE1CET956
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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
N469344010233followed by a unit qualifier and the quantityPackage 69344-0102-33. 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)
INDOCIN 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 INDOCIN 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.
About NDC 69344-102
- What is NDC 69344-102?
- 69344-102 is the product NDC for Indocin (indomethacin), Indomethacin 50 mg/1 suppository, listed with the FDA by Zyla Life Sciences US Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Indocin (Indomethacin).
- What is the active ingredient?
- Indomethacin.
- Who is the labeler?
- Zyla Life Sciences US Inc., NDC labeler code 69344. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Indocin?
- 1 other product NDC are listed under this name. See all Indocin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Indocin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Indocinindomethacin | Indomethacin 25 mg/5mL | SuspensionOral | Zyla Life Sciences US LLC | 69344-101 | 69344-0101-01 |