LORCET HD
- Product NDC
- 51862-587
- 11-digit product format
- 518620587
- Labeler code
- 51862
- Product ID
- 51862-587_2e251033-614c-43c7-8bb4-cf19a32a1c21
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mayne Pharma Inc.
- Application
- ANDA090118
- Marketing category
- ANDA
- Marketing start
- 2016-12-14
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; ACETAMINOPHEN
- Active strength
- 10 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- DEA schedule
- CII
- 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 |
|---|---|---|---|---|---|
| 51862-587-01 | 2020-09-16 | C162847 | 48780-1 | ab0e2407-3491-f274-e053-dbdaa90a6471 | 65ad9e52-b987-4970-beb9-af23391df26f |
| 51862-587-05 | 2020-09-16 | C162847 | 48780-1 | ab0e2407-3491-f274-e053-dbdaa90a6471 | 65ad9e52-b987-4970-beb9-af23391df26f |
| 51862-587-01 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-3491-f274-e053-dbdaa90a6471 | 65ad9e52-b987-4970-beb9-af23391df26f |
| 51862-587-05 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-3491-f274-e053-dbdaa90a6471 | 65ad9e52-b987-4970-beb9-af23391df26f |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51862-587-01 | EA - Each | 51862-587 | 1d145614-9eff-45b0-a035-48f0939456d1 | 1 | 2017-03-06 |
| 51862-587-05 | EA - Each | 51862-587 | de7af667-1db1-4910-8e13-61195022f0f0 | 1 | 2017-03-06 |