Gabapentin
- Product NDC
- 59063-127
- 11-digit product format
- 590630127
- Labeler code
- 59063
- Product ID
- 59063-127_ce4a0985-fac9-4688-9a48-0f2943bf6434
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gabapentin
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Kiel Laboratories, Inc.
- Application
- ANDA076403
- Marketing category
- ANDA
- Marketing start
- 2012-05-01
- Marketing end
- 0000-00-00
- Substance
- GABAPENTIN
- Active strength
- 250 mg/5mL
- Pharmacologic classes
- Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cdc2ae60-922e-452d-a42f-787fe4e2ed06 | Product name | 1 | 20250123 |
| 7059096a-4b9f-36c2-db50-bb5c723e6e9e | Product name | 2 | 20250114 |
| fa3f0129-3502-889f-f424-3a37727959e7 | Product name | 9 | 20181206 |
| 77d89e4c-f57f-326d-d7aa-787f8eebbd2b | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 59063-127-47 | 2019-11-13 | C162847 | 48780-1 | 97449f38-ba2f-f6ea-e053-dbdaa90aa703 | Gabapentin Oral Solution 250 mg / 5 mL R X ONLY |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59063-127-47 | Gabapentin | 470 mL in 1 BOTTLE | SOLUTION | 470 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| GABAPENTIN | ACTIVE INGREDIENT | 6CW7F3G59X | GABAPENTIN SOLUTION [KIEL LABORATORIES, INC.] | 1 | |
| GABAPENTIN | ACTIVE MOIETY | 6CW7F3G59X | GABAPENTIN SOLUTION [KIEL LABORATORIES, INC.] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | GABAPENTIN SOLUTION [KIEL LABORATORIES, INC.] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | GABAPENTIN SOLUTION [KIEL LABORATORIES, INC.] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | GABAPENTIN SOLUTION [KIEL LABORATORIES, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | GABAPENTIN SOLUTION [KIEL LABORATORIES, INC.] | 1 | |
| XYLITOL | INACTIVE INGREDIENT | VCQ006KQ1E | GABAPENTIN SOLUTION [KIEL LABORATORIES, INC.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 283523 | gabapentin 250 MG in 5 mL Oral Solution | PSN | ce4a0985-fac9-4688-9a48-0f2943bf6434 | 1 |
| 283523 | gabapentin 50 MG/ML Oral Solution | SCD | ce4a0985-fac9-4688-9a48-0f2943bf6434 | 1 |
| 283523 | gabapentin 250 MG per 5 ML Oral Solution | SY | ce4a0985-fac9-4688-9a48-0f2943bf6434 | 1 |
| 283523 | gabapentin 300 MG per 6 ML Oral Solution | SY | ce4a0985-fac9-4688-9a48-0f2943bf6434 | 1 |
| 283523 | gabapentin 500 MG per 10 ML Oral Solution | SY | ce4a0985-fac9-4688-9a48-0f2943bf6434 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 59063-127-47 | 59063012747 | 470 mL in 1 BOTTLE | 470 ml | Historical |