Prescription drug · NDA
Indocin (Indomethacin) NDC 69344-101
Indomethacin 25 mg/5mL · Suspension · Oral · Zyla Life Sciences US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69344-101-01 | 6934401010169344010101 | 1 BOTTLE, GLASS in 1 CARTON (69344-101-01) / 237 mL in 1 BOTTLE, GLASSMarketed from Feb 4, 2019 |
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 — 25 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Zyla Life Sciences US LLCNDC labeler code 69344
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018332
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 69344-101_58959f55-f324-4433-97fc-c3b1b7c199beSPL ID 58959f55-f324-4433-97fc-c3b1b7c199beSPL set ID 73878376-1d24-423b-9f37-3666e83c95daRxCUI 206971, 310991UNII XXE1CET956UPC 0369344101010
- 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 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
N469344010101followed by a unit qualifier and the quantityPackage 69344-0101-01. 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)
INDOCIN Oral Suspension 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 69344-101
- What is NDC 69344-101?
- 69344-101 is the product NDC for Indocin (indomethacin), Indomethacin 25 mg/5mL suspension, listed with the FDA by Zyla Life Sciences US LLC. 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 LLC, 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 50 mg/1 | SuppositoryRectal | Zyla Life Sciences US Inc. | 69344-102 | 69344-0102-33 |