Prescription drug · ANDA
Esomeprazole Magnesium for delayed-release oral suspension (Esomeprazole magnesium) NDC 13668-547
Esomeprazole magnesium 5 mg/1 · Granule, Delayed release · Oral · Torrent Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13668-547-94 | 13668054794 | 30 GRANULE, DELAYED RELEASE in 1 CARTON (13668-547-94)Marketed from Mar 5, 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)
- Esomeprazole Magnesium for delayed-release oral suspensionSuffix: for delayed-release oral suspension
- Generic name (nonproprietary)
- esomeprazole magnesium
- Active ingredients
- Esomeprazole magnesium — 5 mg/1
- Dosage form
- Granule, Delayed release
- Route
- Oral
- Labeler
- Torrent Pharmaceuticals LimitedNDC labeler code 13668
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212651
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 13668-547_3e6da063-fd01-4d9f-8b56-5e7cf3e15223SPL ID 3e6da063-fd01-4d9f-8b56-5e7cf3e15223SPL set ID 992b1830-55cc-4e95-8d6d-e7f796d5b373RxCUI 692576, 692578, 1297658, 1297761UNII R6DXU4WAY9UPC 0313668546842
- 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
N413668054794followed by a unit qualifier and the quantityPackage 13668-0547-94. 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)
Esomeprazole magnesium for delayed-release oral suspension is a proton pump inhibitor (PPI). Esomeprazole magnesium for delayed-release oral suspension is indicated for the: Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. ( 1.1 ) Maintenance of healing of EE in adults. ( 1.2 ) Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. ( 1.3 ) Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric …
Excerpt only. Read the full label for complete information.
About NDC 13668-547
- What is NDC 13668-547?
- 13668-547 is the product NDC for Esomeprazole Magnesium for delayed-release oral suspension, Esomeprazole magnesium 5 mg/1 granule, delayed release, listed with the FDA by Torrent Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Esomeprazole Magnesium for delayed-release oral suspension (Esomeprazole Magnesium).
- What is the active ingredient?
- Esomeprazole magnesium.
- Who is the labeler?
- Torrent Pharmaceuticals Limited, NDC labeler code 13668. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Esomeprazole Magnesium for delayed-release oral suspension?
- 4 other product NDCs are listed under this name. See all Esomeprazole Magnesium for delayed-release oral suspension NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Esomeprazole Magnesium for delayed-release oral suspension products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Esomeprazole Magnesium for delayed-release oral suspensionesomeprazole magnesium | Esomeprazole magnesium 2.5 mg/1 | Granule, Delayed releaseOral | Torrent Pharmaceuticals Limited | 13668-546 | 13668-0546-94 |
| Esomeprazole Magnesium for delayed-release oral suspensionesomeprazole magnesium | Esomeprazole magnesium 10 mg/1 | Granule, Delayed releaseOral | Torrent Pharmaceuticals Limited | 13668-548 | 13668-0548-94 |
| Esomeprazole Magnesium for delayed-release oral suspensionesomeprazole magnesium | Esomeprazole magnesium 20 mg/1 | Granule, Delayed releaseOral | Torrent Pharmaceuticals Limited | 13668-549 | 13668-0549-94 |
| Esomeprazole Magnesium for delayed-release oral suspensionesomeprazole magnesium | Esomeprazole magnesium 40 mg/1 | Granule, Delayed releaseOral | Torrent Pharmaceuticals Limited | 13668-550 | 13668-0550-94 |
Other NDCs under ANDA 212651
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Esomeprazole Magnesium for delayed-release oral suspensionesomeprazole magnesium | Esomeprazole magnesium 2.5 mg/1 | Granule, Delayed releaseOral | Torrent Pharmaceuticals Limited | 13668-546 |
| Esomeprazole Magnesium for delayed-release oral suspensionesomeprazole magnesium | Esomeprazole magnesium 40 mg/1 | Granule, Delayed releaseOral | Torrent Pharmaceuticals Limited | 13668-550 |
| Esomeprazole Magnesium for delayed-release oral suspensionesomeprazole magnesium | Esomeprazole magnesium 20 mg/1 | Granule, Delayed releaseOral | Torrent Pharmaceuticals Limited | 13668-549 |