Prescription drug · ANDA
PANTOPRAZOLE SODIUM DELAYED-RELEASE delayed release (Pantoprazole sodium granules) NDC 69097-531
Pantoprazole sodium 40 mg/1 · Suspension · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-531-53 | 6909705315369097053153 | 30 PACKET in 1 CARTON (69097-531-53) / 1 SUSPENSION in 1 PACKET (69097-531-31)Marketed from Apr 3, 2025 |
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)
- PANTOPRAZOLE SODIUM DELAYED-RELEASE delayed releaseSuffix: delayed release
- Generic name (nonproprietary)
- pantoprazole sodium granules
- Active ingredients
- Pantoprazole sodium — 40 mg/1
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Cipla USA Inc.NDC labeler code 69097
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217458
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 69097-531_176f3856-e33d-4fb2-9fe9-72d96c5eabe8SPL ID 176f3856-e33d-4fb2-9fe9-72d96c5eabe8SPL set ID 195e06db-b76c-4470-b6a5-a3979c25046dRxCUI 763306UNII 6871619Q5X
- Pharmacologic class
- Proton Pump Inhibitor
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
N469097053153followed by a unit qualifier and the quantityPackage 69097-0531-53. 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 .
Indications (excerpt from the label)
Pantoprazole sodium for delayed-release oral suspension is indicated for: Pantoprazole sodium is a proton pump inhibitor (PPI) indicated for the following: Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) ( 1.1 ) Maintenance of Healing of Erosive Esophagitis ( 1.2 ) Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome ( 1.3 ) 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole sodium for delayed-release oral suspension is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing a…
Excerpt only. Read the full label for complete information.
About NDC 69097-531
- What is NDC 69097-531?
- 69097-531 is the product NDC for PANTOPRAZOLE SODIUM DELAYED-RELEASE delayed release, Pantoprazole sodium 40 mg/1 suspension, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- PANTOPRAZOLE SODIUM DELAYED-RELEASE delayed release (Pantoprazole sodium granules).
- What is the active ingredient?
- Pantoprazole sodium.
- Who is the labeler?
- Cipla USA Inc., NDC labeler code 69097. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for PANTOPRAZOLE SODIUM DELAYED-RELEASE delayed release?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.