GABAPENTIN
- Product NDC
- 0440-5563
- 11-digit product format
- 004405563
- Labeler code
- 0440
- Product ID
- 0440-5563_29c0c23b-f87d-4a94-a411-4091f399ecd1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gabapentin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Liberty Pharmaceuticals, Inc.
- Application
- ANDA202764
- Marketing category
- ANDA
- Marketing start
- 2012-11-02
- Marketing end
- 0000-00-00
- Substance
- GABAPENTIN
- Active strength
- 800 mg/1
- 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#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 0440-5563-05 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-cffa-f424-e053-dadaa90a57ce | Gabapentin Tablets, USP Rx Only |
| 0440-5563-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-cffa-f424-e053-dadaa90a57ce | Gabapentin Tablets, USP Rx Only |
| 0440-5563-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-cffa-f424-e053-dadaa90a57ce | Gabapentin Tablets, USP Rx Only |
| 0440-5563-81 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-cffa-f424-e053-dadaa90a57ce | Gabapentin Tablets, USP Rx Only |
| 0440-5563-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-cffa-f424-e053-dadaa90a57ce | Gabapentin Tablets, USP Rx Only |
| 0440-5563-91 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-cffa-f424-e053-dadaa90a57ce | Gabapentin Tablets, USP Rx Only |
| 0440-5563-92 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-cffa-f424-e053-dadaa90a57ce | Gabapentin Tablets, USP Rx Only |
| 0440-5563-94 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-cffa-f424-e053-dadaa90a57ce | Gabapentin Tablets, USP Rx Only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0440-5563-05 | GABAPENTIN | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 1 |
| 0440-5563-30 | GABAPENTIN | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 0440-5563-60 | GABAPENTIN | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 0440-5563-81 | GABAPENTIN | 300 in 1 BOTTLE | TABLET, FILM COATED | 300 | | 1 |
| 0440-5563-90 | GABAPENTIN | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
| 0440-5563-91 | GABAPENTIN | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 1 |
| 0440-5563-92 | GABAPENTIN | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 1 |
| 0440-5563-94 | GABAPENTIN | 270 in 1 BOTTLE | TABLET, FILM COATED | 270 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0440-5563 | GABAPENTIN TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 8 package rows | 20160810_0002eded-a283-4590-a78c-b6ff2027e684.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 0440-5563-05 | 00440556305 | 500 in 1 BOTTLE | Historical |
| 0440-5563-30 | 00440556330 | 30 in 1 BOTTLE | Historical |
| 0440-5563-60 | 00440556360 | 60 in 1 BOTTLE | Historical |
| 0440-5563-81 | 00440556381 | 300 in 1 BOTTLE | Historical |
| 0440-5563-90 | 00440556390 | 90 in 1 BOTTLE | Historical |
| 0440-5563-91 | 00440556391 | 120 in 1 BOTTLE | Historical |
| 0440-5563-92 | 00440556392 | 180 in 1 BOTTLE | Historical |
| 0440-5563-94 | 00440556394 | 270 in 1 BOTTLE | Historical |