Doxycycline Hyclate
- Product NDC
- 51862-571
- Requested package NDC
- 51862-571-30
- 11-digit product format
- 518620571
- Labeler code
- 51862
- Product ID
- 51862-571_b6329a99-ca11-4da2-845e-eafa14443468
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxycycline Hyclate
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Mayne Pharma
- Application
- NDA050795
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2020-10-02
- Marketing end
- 0000-00-00
- Substance
- DOXYCYCLINE HYCLATE
- Active strength
- 80 mg/1
- Pharmacologic classes
- Tetracycline-class Drug [EPC], Tetracyclines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 51862-571 | 51862-571-30 | D | Discontinued by firm | 2026-08-07 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050795-001 | DORYX | DOXYCYCLINE HYCLATE | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2005-05-06 | |
| N050795-002 | DORYX | DOXYCYCLINE HYCLATE | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2005-05-06 | |
| N050795-003 | DORYX | DOXYCYCLINE HYCLATE | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2008-06-20 | |
| N050795-004 | DORYX | DOXYCYCLINE HYCLATE | EQ 80MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2013-04-11 | |
| N050795-005 | DORYX | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2013-04-11 | |
| N050795-006 | DORYX | DOXYCYCLINE HYCLATE | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2014-12-19 | |
| N050795-007 | DORYX MPC | DOXYCYCLINE HYCLATE | EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2016-05-20 | |
| N050795-008 | DORYX MPC | DOXYCYCLINE HYCLATE | EQ 120MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2016-05-20 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N050795-001 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | |
| N050795-002 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | |
| N050795-003 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | |
| N050795-004 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | |
| N050795-005 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | |
| N050795-006 | 8715724 | 2028-02-03 | Drug product | 2015-02-10 | |
| N050795-007 | 8715724 | 2028-02-03 | Drug product | 2016-05-23 | |
| N050795-007 | 9295652 | 2034-10-23 | U-918 | Drug product | 2016-05-23 |
| N050795-007 | 9511031 | 2034-10-23 | Drug product | 2017-01-05 | |
| N050795-007 | 9446057 | 2034-12-23 | U-918 | Drug product | 2016-09-09 |
| N050795-008 | 8715724 | 2028-02-03 | Drug product | 2016-05-23 | |
| N050795-008 | 9295652 | 2034-10-23 | U-918 | Drug product | 2016-05-23 |
| N050795-008 | 9511031 | 2034-10-23 | Drug product | 2017-01-05 | |
| N050795-008 | 9446057 | 2034-12-23 | U-918 | Drug product | 2016-09-09 |
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 | N050795-001 | DORYX | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2005-05-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-002 | DORYX | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2005-05-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-003 | DORYX | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2008-06-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-004 | DORYX | EQ 80MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2013-04-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-005 | DORYX | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2013-04-11 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-006 | DORYX | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2014-12-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-007 | DORYX MPC | EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2016-05-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-008 | DORYX MPC | EQ 120MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2016-05-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-001 | DORYX | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2005-05-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-002 | DORYX | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2005-05-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-003 | DORYX | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2008-06-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-004 | DORYX | EQ 80MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2013-04-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-005 | DORYX | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2013-04-11 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-006 | DORYX | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2014-12-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-007 | DORYX MPC | EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2016-05-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-008 | DORYX MPC | EQ 120MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2016-05-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-001 | DORYX | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2005-05-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-002 | DORYX | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2005-05-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-003 | DORYX | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2008-06-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-004 | DORYX | EQ 80MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2013-04-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-005 | DORYX | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2013-04-11 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-006 | DORYX | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2014-12-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-007 | DORYX MPC | EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2016-05-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-008 | DORYX MPC | EQ 120MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2016-05-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050795-001 | DORYX | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2005-05-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050795-002 | DORYX | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2005-05-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050795-003 | DORYX | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2008-06-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050795-004 | DORYX | EQ 80MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2013-04-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050795-005 | DORYX | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2013-04-11 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050795-006 | DORYX | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2014-12-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050795-007 | DORYX MPC | EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2016-05-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050795-008 | DORYX MPC | EQ 120MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2016-05-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050795-001 | DORYX | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2005-05-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050795-002 | DORYX | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2005-05-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050795-003 | DORYX | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2008-06-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050795-004 | DORYX | EQ 80MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2013-04-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050795-005 | DORYX | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2013-04-11 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050795-006 | DORYX | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2014-12-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050795-007 | DORYX MPC | EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2016-05-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050795-008 | DORYX MPC | EQ 120MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2016-05-20 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N050795-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050795-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050795-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050795-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050795-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050795-005 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050795-005 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N050795-005 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050795-005 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050795-005 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050795-005 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N050795-005 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050795-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050795-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050795-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050795-005 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050795-006 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N050795-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N050795-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N050795-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N050795-005 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N050795-006 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N050795-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N050795-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N050795-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N050795-005 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N050795-006 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N050795-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050795-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050795-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050795-005 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050795-006 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N050795-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N050795-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N050795-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N050795-005 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N050795-006 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N050795-001 | AB | 1 | 782e0a99824c… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N050795-001 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-002 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-003 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-004 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-005 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-006 | 8715724 | 2028-02-03 | Drug product | 2015-02-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-007 | 8715724 | 2028-02-03 | Drug product | 2016-05-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-007 | 9295652 | 2034-10-23 | U-918 | Drug product | 2016-05-23 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-007 | 9511031 | 2034-10-23 | Drug product | 2017-01-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-007 | 9446057 | 2034-12-23 | U-918 | Drug product | 2016-09-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-008 | 8715724 | 2028-02-03 | Drug product | 2016-05-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-008 | 9295652 | 2034-10-23 | U-918 | Drug product | 2016-05-23 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-008 | 9511031 | 2034-10-23 | Drug product | 2017-01-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-008 | 9446057 | 2034-12-23 | U-918 | Drug product | 2016-09-09 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-001 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-002 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-003 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-004 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-005 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-006 | 8715724 | 2028-02-03 | Drug product | 2015-02-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-007 | 8715724 | 2028-02-03 | Drug product | 2016-05-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-007 | 9295652 | 2034-10-23 | U-918 | Drug product | 2016-05-23 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-007 | 9511031 | 2034-10-23 | Drug product | 2017-01-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-007 | 9446057 | 2034-12-23 | U-918 | Drug product | 2016-09-09 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-008 | 8715724 | 2028-02-03 | Drug product | 2016-05-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-008 | 9295652 | 2034-10-23 | U-918 | Drug product | 2016-05-23 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-008 | 9511031 | 2034-10-23 | Drug product | 2017-01-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-008 | 9446057 | 2034-12-23 | U-918 | Drug product | 2016-09-09 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-001 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-002 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-003 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-004 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-005 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-006 | 8715724 | 2028-02-03 | Drug product | 2015-02-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-007 | 8715724 | 2028-02-03 | Drug product | 2016-05-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-007 | 9295652 | 2034-10-23 | U-918 | Drug product | 2016-05-23 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-007 | 9511031 | 2034-10-23 | Drug product | 2017-01-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-007 | 9446057 | 2034-12-23 | U-918 | Drug product | 2016-09-09 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-008 | 8715724 | 2028-02-03 | Drug product | 2016-05-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-008 | 9295652 | 2034-10-23 | U-918 | Drug product | 2016-05-23 | 6a471c1ec25d… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51862-571-30 | EA - Each | 51862-571 | 7f12009b-94e7-4045-a506-632469a44bec | 1 | 2020-09-14 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| DORYX MPC | DOXYCYCLINE HYCLATE | Mayne Pharma Commercial LLC | f9277bb8-982d-444d-9325-35d5c53a2d35 | 2026-02-16 | Warnings, Adverse reactions | 050795 NDA050795 |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Mayne Pharma Commercial LLC | cd2ab9b8-9619-4199-8a5d-83377b3274d1 | 2025-04-14 | Warnings, Adverse reactions | 050795 NDA050795 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51862-571-30 | 51862057130 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-571-30) | 2020-10-02 | 0000-00-00 | No | No | Current |