GABAPENTIN
- Product NDC
- 61919-839
- 11-digit product format
- 619190839
- Labeler code
- 61919
- Product ID
- 61919-839_9c9437d9-bf92-2a03-e053-2a95a90aeded
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GABAPENTIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA075350
- Marketing category
- ANDA
- Marketing start
- 2016-03-30
- Marketing end
- 0000-00-00
- Substance
- GABAPENTIN
- Active strength
- 300 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| fa3f0129-3502-889f-f424-3a37727959e7 | Product name | 9 | 20181206 |
| 77d89e4c-f57f-326d-d7aa-787f8eebbd2b | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61919-839-72 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ba9f-a426-e053-dadaa90af4c2 | GABAPENTIN 300mg 120 CAPS |
| 61919-839-99 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ba9f-a426-e053-dadaa90af4c2 | GABAPENTIN 300mg 120 CAPS |
| 61919-839-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a414-f424-e053-dadaa90a57ce | GABAPENTIN 300mg 30CAPS |
| 61919-839-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-779e-f424-e053-dadaa90a57ce | GABAPENTIN 300mg |
| 61919-839-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4b6a-f424-e053-dadaa90a57ce | GABAPENTIN 300mg 90CAPS |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61919-839-72 | GABAPENTIN | 120 in 1 BOTTLE | CAPSULE | 120 | 3 | |
| 61919-839-99 | GABAPENTIN | 84 in 1 BOTTLE | CAPSULE | 84 | 3 | |
| 61919-839-30 | GABAPENTIN | 30 in 1 BOTTLE | CAPSULE | 30 | 1 | |
| 61919-839-60 | GABAPENTIN | 60 in 1 BOTTLE | CAPSULE | 60 | 1 | |
| 61919-839-90 | GABAPENTIN | 90 in 1 BOTTLE | CAPSULE | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-839-30 | EA - Each | 61919-839 | 381d7cdb-6a72-42e5-a626-da3ee994e2b2 | 1 | 2016-06-14 |
| 61919-839-60 | EA - Each | 61919-839 | 29cd7755-cb08-436d-a663-dbe8aa59431f | 1 | 2016-06-14 |
| 61919-839-72 | EA - Each | 61919-839 | 51c2c801-e595-42cd-b391-0e02f8bdb10a | 1 | 2016-06-14 |
| 61919-839-90 | EA - Each | 61919-839 | 6aed0235-490b-4a12-b9a7-e79bd5288a33 | 1 | 2016-06-14 |
| 61919-839-99 | EA - Each | 61919-839 | 8e015fd6-e3a2-411a-8855-5579cdecadca | 1 | 2019-08-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61919-839 | GABAPENTIN CAPSULE [DIRECT RX] | 3 | Legacy NDC, 2 package rows | 20200131_2faccf5e-9a81-3a3a-e054-00144ff8d46c.zip |
| 61919-839 | GABAPENTIN CAPSULE [DIRECT RX] | 1 | Legacy NDC, 1 package rows | 20160404_2f5e3466-1710-1532-e054-00144ff8d46c.zip |
| 61919-839 | GABAPENTIN CAPSULE [DIRECT RX] | 1 | Legacy NDC, 1 package rows | 20160404_2fab077c-d3f3-5f8f-e054-00144ff8d46c.zip |
| 61919-839 | GABAPENTIN CAPSULE [DIRECT RX] | 1 | Legacy NDC, 1 package rows | 20160331_2f5ac7c6-a926-57df-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310431 | gabapentin 300 MG Oral Capsule | PSN | 2faccf5e-9a81-3a3a-e054-00144ff8d46c | 3 |
| 310431 | gabapentin 300 MG Oral Capsule | SCD | 2faccf5e-9a81-3a3a-e054-00144ff8d46c | 3 |
| 310431 | gabapentin 300 MG Oral Capsule | PSN | 2f5ac7c6-a926-57df-e054-00144ff8d46c | 1 |
| 310431 | gabapentin 300 MG Oral Capsule | PSN | 2f5e3466-1710-1532-e054-00144ff8d46c | 1 |
| 310431 | gabapentin 300 MG Oral Capsule | PSN | 2fab077c-d3f3-5f8f-e054-00144ff8d46c | 1 |
| 310431 | gabapentin 300 MG Oral Capsule | SCD | 2f5ac7c6-a926-57df-e054-00144ff8d46c | 1 |
| 310431 | gabapentin 300 MG Oral Capsule | SCD | 2f5e3466-1710-1532-e054-00144ff8d46c | 1 |
| 310431 | gabapentin 300 MG Oral Capsule | SCD | 2fab077c-d3f3-5f8f-e054-00144ff8d46c | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61919-839-30 | 61919083930 | 30 in 1 BOTTLE | Historical | |||||
| 61919-839-60 | 61919083960 | 60 in 1 BOTTLE | Historical | |||||
| 61919-839-72 | 61919083972 | 120 CAPSULE in 1 BOTTLE (61919-839-72) | 120 capsule | 2016-03-30 | 0000-00-00 | No | No | Current |
| 61919-839-90 | 61919083990 | 90 in 1 BOTTLE | Historical | |||||
| 61919-839-99 | 61919083999 | 84 CAPSULE in 1 BOTTLE (61919-839-99) | 84 capsule | 2016-03-30 | 0000-00-00 | No | No | Current |