Tramadol Hydrochloride
- Product NDC
- 68788-7284
- 11-digit product format
- 687887284
- Labeler code
- 68788
- Product ID
- 68788-7284_2f3e5dc7-cb04-470c-9280-aaf0532b3676
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tramadol hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA205257
- Marketing category
- ANDA
- Marketing start
- 2019-01-17
- Marketing end
- 0000-00-00
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68788-7284-2 | 2021-02-02 | C162847 | 48780-1 | ba0f9c33-0f1f-a910-e053-dadaa90a0b85 | 2f3e5dc7-cb04-470c-9280-aaf0532b3676 |
| 68788-7284-3 | 2021-02-02 | C162847 | 48780-1 | ba0f9c33-0f1f-a910-e053-dadaa90a0b85 | 2f3e5dc7-cb04-470c-9280-aaf0532b3676 |
| 68788-7284-6 | 2021-02-02 | C162847 | 48780-1 | ba0f9c33-0f1f-a910-e053-dadaa90a0b85 | 2f3e5dc7-cb04-470c-9280-aaf0532b3676 |
| 68788-7284-9 | 2021-02-02 | C162847 | 48780-1 | ba0f9c33-0f1f-a910-e053-dadaa90a0b85 | 2f3e5dc7-cb04-470c-9280-aaf0532b3676 |
| 68788-7284-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-0f1f-a910-e053-dadaa90a0b85 | 2f3e5dc7-cb04-470c-9280-aaf0532b3676 |
| 68788-7284-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-0f1f-a910-e053-dadaa90a0b85 | 2f3e5dc7-cb04-470c-9280-aaf0532b3676 |
| 68788-7284-6 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-0f1f-a910-e053-dadaa90a0b85 | 2f3e5dc7-cb04-470c-9280-aaf0532b3676 |
| 68788-7284-9 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-0f1f-a910-e053-dadaa90a0b85 | 2f3e5dc7-cb04-470c-9280-aaf0532b3676 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-7284-2 | EA - Each | 68788-7284 | 1270e7b2-770c-48f8-a3be-c94cb36a7dac | 1 | 2019-03-12 |
| 68788-7284-3 | EA - Each | 68788-7284 | 0de8bb03-4b83-47a9-aa10-24bbd0906ddd | 1 | 2019-03-12 |
| 68788-7284-6 | EA - Each | 68788-7284 | ba016fa0-eee6-4312-8146-f19eea551328 | 1 | 2019-03-12 |
| 68788-7284-9 | EA - Each | 68788-7284 | ee131048-029b-4be8-a902-e2ec0ca48be9 | 1 | 2019-03-12 |