LORCET
- Product NDC
- 51862-585
- 11-digit product format
- 518620585
- Labeler code
- 51862
- Product ID
- 51862-585_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
- 5 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
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 51862-585-01 | 2020-09-16 | C162847 | 48780-1 | ab0e2407-3491-f274-e053-dbdaa90a6471 | 65ad9e52-b987-4970-beb9-af23391df26f |
| 51862-585-05 | 2020-09-16 | C162847 | 48780-1 | ab0e2407-3491-f274-e053-dbdaa90a6471 | 65ad9e52-b987-4970-beb9-af23391df26f |
| 51862-585-01 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-3491-f274-e053-dbdaa90a6471 | 65ad9e52-b987-4970-beb9-af23391df26f |
| 51862-585-05 | 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 |
|---|---|---|---|---|---|
| 51862-585-01 | EA - Each | 51862-585 | dad4a992-ef9b-4a5c-8fe4-3963bc18495a | 1 | 2017-09-11 |
| 51862-585-05 | EA - Each | 51862-585 | fc798fbd-71e0-43eb-91fe-be0cfa2728c3 | 1 | 2017-03-06 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 857002 | HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet | PSN | 208eb5d8-741d-44f8-9100-432294d7be7e | 6 |
| 857002 | acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet | SCD | 208eb5d8-741d-44f8-9100-432294d7be7e | 6 |
| 857002 | APAP 325 MG / hydrocodone bitartrate 5 MG Oral Tablet | SY | 208eb5d8-741d-44f8-9100-432294d7be7e | 6 |
| 857002 | HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet | PSN | da60f2ed-8127-4031-94c4-d616473ac07a | 3 |
| 857002 | acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet | SCD | da60f2ed-8127-4031-94c4-d616473ac07a | 3 |
| 857002 | APAP 325 MG / hydrocodone bitartrate 5 MG Oral Tablet | SY | da60f2ed-8127-4031-94c4-d616473ac07a | 3 |