Gabapentin
- Product NDC
- 17856-0311
- 11-digit product format
- 178560311
- Labeler code
- 17856
- Product ID
- 17856-0311_a85eb3d4-e7d4-4a52-87fd-5d57e2732175
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Atlantic Biologicals Corps
- Application
- ANDA078974
- Marketing category
- ANDA
- Marketing start
- 2011-02-23
- 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
- 2018-12-31
- 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 |
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| fa3f0129-3502-889f-f424-3a37727959e7 | Product name | 9 | 20181206 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 77d89e4c-f57f-326d-d7aa-787f8eebbd2b | Product name | 1 | 20140508 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 17856-0311-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4c2a-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN oral solution Initial U.S. Approval: 1993 |
| 17856-0311-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4c2a-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN oral solution Initial U.S. Approval: 1993 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17856-0311-2 | Gabapentin | 6 mL in 1 CUP | SOLUTION | 6 | 9 | |
| 17856-0311-3 | Gabapentin | 6 mL in 1 CUP | SOLUTION | 6 | 9 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 17856-0311 | GABAPENTIN SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 9 | Legacy NDC, 2 package rows | 20160909_31e18a2a-b43f-4b53-a51d-7479781bae7c.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 283523 | gabapentin 250 MG in 5 mL Oral Solution | PSN | 31e18a2a-b43f-4b53-a51d-7479781bae7c | 9 |
| 283523 | gabapentin 50 MG/ML Oral Solution | SCD | 31e18a2a-b43f-4b53-a51d-7479781bae7c | 9 |
| 283523 | gabapentin 250 MG per 5 ML Oral Solution | SY | 31e18a2a-b43f-4b53-a51d-7479781bae7c | 9 |
| 283523 | gabapentin 300 MG per 6 ML Oral Solution | SY | 31e18a2a-b43f-4b53-a51d-7479781bae7c | 9 |
| 283523 | gabapentin 500 MG per 10 ML Oral Solution | SY | 31e18a2a-b43f-4b53-a51d-7479781bae7c | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 17856-0311-2 | 17856031102 | 6 mL in 1 CUP | 6 ml | Historical |
| 17856-0311-3 | 17856031103 | 6 mL in 1 CUP | 6 ml | Historical |