Prescription drug · NDA
Gattex (Teduglutide) NDC 68875-0102
Kit · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68875-0102-1 | 68875010201 | 1 KIT in 1 CARTON (68875-0102-1) * .5 mL in 1 SYRINGE, PLASTIC * .7 mL in 1 PACKET * .5 mL in 1 VIAL (68875-0101-1)Marketed from Dec 21, 2012 |
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)
- Gattex
- Generic name (nonproprietary)
- teduglutide
- Dosage form
- Kit
- Labeler
- Takeda Pharmaceuticals America, Inc.NDC labeler code 68875
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203441
- Marketing start
- Listing expires
- Identifiers
- Product ID 68875-0102_20ca0019-d3a4-4a8f-8dd4-67179d06e4dcSPL ID 20ca0019-d3a4-4a8f-8dd4-67179d06e4dcSPL set ID 66b69c1e-b25c-44d3-b5ff-1c1de9a516faRxCUI 1364472, 1364477, 1489307UNII 7M19191IKG
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
N468875010201followed by a unit qualifier and the quantityPackage 68875-0102-01. 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 .
Indications (excerpt from the label)
GATTEX ® is indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support . GATTEX ® is a glucagon-like peptide-2 (GLP-2) analog indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 68875-0102
- What is NDC 68875-0102?
- 68875-0102 is the product NDC for Gattex (teduglutide) kit, listed with the FDA by Takeda Pharmaceuticals America, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gattex (Teduglutide).
- Who is the labeler?
- Takeda Pharmaceuticals America, Inc., NDC labeler code 68875. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gattex?
- 2 other product NDCs are listed under this name. See all Gattex NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gattex products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gattexteduglutide | Teduglutide 5 mg/.5mL | Injection, Powder, Lyophilized, For solutionSubcutaneous | Takeda Pharmaceuticals America, Inc. | 68875-0101 | 68875-0101-02 |
| Gattexteduglutide | — | Kit | Takeda Pharmaceuticals America, Inc. | 68875-0103 | 68875-0103-01 |
Other NDCs under NDA 203441
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 |
|---|---|---|---|---|
| Gattexteduglutide | Teduglutide 5 mg/.5mL | Injection, Powder, Lyophilized, For solutionSubcutaneous | Takeda Pharmaceuticals America, Inc. | 68875-0101 |
| Gattexteduglutide | — | Kit | Takeda Pharmaceuticals America, Inc. | 68875-0103 |