Application 005213
- Type
- NDA
- Sponsor
- GENUS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYCODAN | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | TABLET;ORAL | 1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | HYCODAN | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | SYRUP;ORAL | 1.5MG/5ML;5MG/5ML | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N005213-001 | HYCODAN | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | 1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD | 1988-07-26 |
| N005213-002 | HYCODAN | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | 1.5MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | AA | RLD | 1988-07-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N005213-001 | AA |
| N005213-002 | AA |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N005213-001 | HYCODAN | 1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD | 1988-07-26 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N005213-002 | HYCODAN | 1.5MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | AA | RLD | 1988-07-26 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N005213-001 | HYCODAN | 1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD | 1988-07-26 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N005213-002 | HYCODAN | 1.5MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | AA | RLD | 1988-07-26 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N005213-001 | HYCODAN | 1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD | 1988-07-26 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N005213-002 | HYCODAN | 1.5MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | AA | RLD | 1988-07-26 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N005213-001 | HYCODAN | 1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD | 1988-07-26 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N005213-002 | HYCODAN | 1.5MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | AA | RLD | 1988-07-26 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N005213-001 | HYCODAN | 1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD | 1988-07-26 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N005213-002 | HYCODAN | 1.5MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | AA | RLD | 1988-07-26 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N005213-001 | HYCODAN | 1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD | 1988-07-26 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N005213-002 | HYCODAN | 1.5MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | AA | RLD | 1988-07-26 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N005213-001 | HYCODAN | 1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD | 1988-07-26 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N005213-002 | HYCODAN | 1.5MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | AA | RLD | 1988-07-26 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N005213-001 | HYCODAN | 1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD | 1988-07-26 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N005213-002 | HYCODAN | 1.5MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | AA | RLD | 1988-07-26 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N005213-001 | HYCODAN | 1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD | 1988-07-26 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N005213-002 | HYCODAN | 1.5MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | AA | RLD | 1988-07-26 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N005213-001 | HYCODAN | 1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD | 1988-07-26 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N005213-002 | HYCODAN | 1.5MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | AA | RLD | 1988-07-26 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N005213-001 | HYCODAN | 1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD | 1988-07-26 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N005213-002 | HYCODAN | 1.5MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | AA | RLD | 1988-07-26 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N005213-001 | HYCODAN | 1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD | 1988-07-26 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N005213-002 | HYCODAN | 1.5MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | AA | RLD | 1988-07-26 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N005213-001 | HYCODAN | 1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD | 1988-07-26 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N005213-002 | HYCODAN | 1.5MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | AA | RLD | 1988-07-26 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N005213-001 | HYCODAN | 1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD | 1988-07-26 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N005213-002 | HYCODAN | 1.5MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | AA | RLD | 1988-07-26 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N005213-001 | HYCODAN | 1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD | 1988-07-26 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N005213-002 | HYCODAN | 1.5MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | AA | RLD | 1988-07-26 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N005213-001 | HYCODAN | 1.5MG;5MG | TABLET / ORAL | AA | RLD | 1988-07-26 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N005213-002 | HYCODAN | 1.5MG/5ML;5MG/5ML | SYRUP / ORAL | AA | RLD | 1988-07-26 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N005213-001 | HYCODAN | 1.5MG;5MG | TABLET / ORAL | AA | RLD | 1988-07-26 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N005213-002 | HYCODAN | 1.5MG/5ML;5MG/5ML | SYRUP / ORAL | AA | RLD | 1988-07-26 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N005213-001 | HYCODAN | 1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1988-07-26 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N005213-002 | HYCODAN | 1.5MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SYRUP / ORAL | AA | RLD | 1988-07-26 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N005213-001 | HYCODAN | 1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD | 1988-07-26 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N005213-002 | HYCODAN | 1.5MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | AA | RLD | 1988-07-26 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N005213-001 | HYCODAN | 1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | AA | RLD | 1988-07-26 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N005213-002 | HYCODAN | 1.5MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SYRUP / ORAL | AA | RLD | 1988-07-26 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N005213-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N005213-002 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N005213-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N005213-002 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N005213-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N005213-002 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N005213-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N005213-002 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N005213-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N005213-002 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N005213-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N005213-002 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N005213-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N005213-002 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N005213-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N005213-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N005213-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N005213-002 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N005213-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N005213-002 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N005213-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N005213-002 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N005213-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N005213-002 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N005213-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N005213-002 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N005213-001 | AA | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N005213-002 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N005213-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N005213-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N005213-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N005213-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N005213-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N005213-002 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N005213-002 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N005213-001 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N005213-002 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N005213-001 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N005213-002 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N005213-002 | AA | 1 | 87673890dc5c… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Hydrocodone Bitartrate and Homatropine Methylbromide | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE | Genus Lifesciences Inc. | 320ff639-9854-407b-9bbd-a035c4f173e1 | 2026-05-07 | Boxed warning, Warnings, Adverse reactions | 005213 NDA005213 64950-206 64950-371 |
| Hydrocodone Bitartrate and Homatropine Methylbromide | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE | PAI Holdings, LLC dba PAI Pharma | 71319a6f-aaf4-4bc5-8b40-a16c6f139be6 | 2026-02-28 | Boxed warning, Warnings, Adverse reactions | 005213 NDA005213 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 64950-205 | Hycodan | Hydrocodone Bitartrate and Homatropine Methylbromide | Genus Lifesciences Inc. | NDA | Current |
| 64950-205 | Hycodan | Hydrocodone Bitartrate and Homatropine Methylbromide | Genus Lifesciences Inc. | NDA | Current |
| 64950-205 | Hycodan | Hydrocodone Bitartrate and Homatropine Methylbromide | Genus Lifesciences Inc. | NDA | Current |
| 64950-206 | Hydrocodone Bitartrate and Homatropine Methylbromide | Hydrocodone Bitartrate and Homatropine Methylbromide | Genus Lifesciences Inc. | NDA AUTHORIZED GENERIC | Current |
| 64950-342 | Hycodan | Hydrocodone Bitartrate and Homatropine Methylbromide | Genus Lifesciences Inc. | NDA | Current |
| 64950-342 | Hycodan | Hydrocodone Bitartrate and Homatropine Methylbromide | Genus Lifesciences Inc. | NDA | Current |
| 64950-342 | Hycodan | Hydrocodone Bitartrate and Homatropine Methylbromide | Genus Lifesciences Inc. | NDA | Current |
| 64950-342 | Hycodan | Hydrocodone Bitartrate and Homatropine Methylbromide | Genus Lifesciences Inc. | NDA | Current |
| 64950-342 | Hycodan | Hydrocodone Bitartrate and Homatropine Methylbromide | Genus Lifesciences Inc. | NDA | Current |
| 64950-371 | Hydrocodone Bitartrate and Homatropine Methylbromide | Hydrocodone Bitartrate and Homatropine Methylbromide | Genus Lifesciences Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84714 | SUPPL | 2026-01-07 |
| 84527 | SUPPL | 2025-12-23 |
| 76907 | SUPPL | 2023-12-18 |
| 76906 | SUPPL | 2023-12-18 |
| 68866 | SUPPL | 2021-10-04 |
| 68865 | SUPPL | 2021-10-04 |
| 54850 | SUPPL | 2018-07-06 |
| 54787 | SUPPL | 2018-07-06 |
| 54750 | SUPPL | 2018-07-05 |
| 46896 | SUPPL | 2017-01-19 |
| 46872 | SUPPL | 2017-01-13 |
| 40643 | SUPPL | 2013-02-27 |
| 32926 | SUPPL | 2009-02-04 |
| 14 | SUPPL | 2009-01-30 |