Prescription drug · ANDA
Gabapentin NDC 72189-158
Gabapentin 800 mg/1 · Tablet, Film coated · Oral · DIRECT RX
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-158-30 | 7218901583072189015830 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-158-30)Marketed from Dec 1, 2020 | |
| 72189-158-60 | 7218901586072189015860 | 60 TABLET, FILM COATED in 1 BOTTLE (72189-158-60)Marketed from Dec 1, 2020 | |
| 72189-158-72 | 7218901587272189015872 | 120 TABLET, FILM COATED in 1 BOTTLE (72189-158-72)Marketed from Dec 1, 2020 | |
| 72189-158-90 | 7218901589072189015890 | 90 TABLET, FILM COATED in 1 BOTTLE (72189-158-90)Marketed from Dec 1, 2020 |
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)
- Gabapentin
- Generic name (nonproprietary)
- gabapentin
- Active ingredients
- Gabapentin — 800 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- DIRECT RXNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203244
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 72189-158_2becf606-de3d-b686-e063-6294a90afe58SPL ID 2becf606-de3d-b686-e063-6294a90afe58SPL set ID a7e45e3f-e382-32ba-e053-2a95a90a2537RxCUI 310430, 310432, 310434UNII 6CW7F3G59X
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
N472189015830followed by a unit qualifier and the quantityPackage 72189-0158-30. 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 .
About NDC 72189-158
- What is NDC 72189-158?
- 72189-158 is the product NDC for Gabapentin, Gabapentin 800 mg/1 tablet, film coated, listed with the FDA by DIRECT RX. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gabapentin.
- What is the active ingredient?
- Gabapentin.
- Who is the labeler?
- DIRECT RX, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gabapentin?
- 561 other product NDCs are listed under this name. See all Gabapentin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gabapentin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-943 | 60760-0943-3060760-0943-90 |
| gabapentin | Gabapentin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4763 | 70518-4763-00 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-0581 | 55154-0581-00 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0595 | 80425-0595-0180425-0595-0280425-0595-03+1 more |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4746 | 70518-4746-0070518-4746-0170518-4746-02+1 more |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4742 | 70518-4742-0070518-4742-02 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4740 | 70518-4740-00 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-0580 | 55154-0580-00 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, CoatedOral | Coupler LLC | 67046-1233 | 67046-1233-03 |
| Gabapentin | Gabapentin 200 mg/1 | CapsuleOral | Trifluent Pharma, LLC | 73352-231 | 73352-0231-01 |
Other NDCs under ANDA 203244
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 |
|---|---|---|---|---|
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-066 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-727 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-728 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-160 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-457 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1007 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1026 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1041 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1132 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1601 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-044 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-426 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2141 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2142 |