DOXYCYCLINE HYCLATE
- Product NDC
- 43547-462
- 11-digit product format
- 435470462
- Labeler code
- 43547
- Product ID
- 43547-462_49c9be01-a1bf-48aa-8ef4-0584e8dcaac5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DOXYCYCLINE HYCLATE
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Solco Healthcare US LLC
- Application
- ANDA207494
- Marketing category
- ANDA
- Marketing start
- 2018-11-28
- Substance
- DOXYCYCLINE HYCLATE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Tetracycline-class Drug [EPC], Tetracyclines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207494-001 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | |
| A207494-002 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | |
| A207494-003 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 50MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2019-02-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207494-001 | AB |
| A207494-002 | AB |
| A207494-003 | AB |
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 | A207494-001 | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207494-002 | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207494-003 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2019-02-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207494-001 | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207494-002 | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207494-003 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2019-02-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207494-001 | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207494-002 | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207494-003 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2019-02-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207494-001 | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207494-002 | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207494-003 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2019-02-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207494-001 | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207494-002 | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207494-003 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2019-02-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207494-001 | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207494-002 | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207494-003 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2019-02-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207494-001 | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207494-002 | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207494-003 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2019-02-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207494-001 | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207494-002 | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207494-003 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2019-02-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207494-001 | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207494-002 | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207494-003 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2019-02-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207494-001 | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207494-002 | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207494-003 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2019-02-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207494-001 | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207494-002 | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207494-003 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2019-02-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207494-001 | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207494-002 | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207494-003 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2019-02-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207494-001 | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207494-002 | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207494-003 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2019-02-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A207494-001 | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2016-11-15 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A207494-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207494-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207494-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207494-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207494-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207494-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207494-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207494-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207494-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207494-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207494-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207494-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207494-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207494-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207494-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207494-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207494-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207494-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207494-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207494-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207494-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207494-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207494-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207494-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207494-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207494-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207494-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A207494-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207494-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207494-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207494-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207494-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207494-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207494-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207494-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207494-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207494-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207494-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207494-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A207494-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DOXYCYCLINE HYCLATE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DOXYCYCLINE HYCLATE | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 19XTS3T51U | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0a18d4c7-9484-4d3e-b61b-e81fe63fefec | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43547-462-12 | DOXYCYCLINE HYCLATE | 120 in 1 BOTTLE | TABLET, DELAYED RELEASE | 120 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43547-462-12 | EA - Each | 43547-462 | 76e12ea7-0bae-4369-8290-eebc6aaa84db | 1 | 2019-07-02 |
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 |
|---|---|---|---|---|---|---|
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | Solco Healthcare US LLC | 0a18d4c7-9484-4d3e-b61b-e81fe63fefec | 2025-10-31 | Warnings, Adverse reactions | 207494 ANDA207494 43547-462 |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Sonoma Pharmaceuticals, Inc. | 4fa26176-a730-48ed-9659-e2f64212f418 | 2018-05-23 | Warnings, Adverse reactions | 207494 ANDA207494 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 799048 | doxycycline hyclate 150 MG Delayed Release Oral Tablet | PSN | 0a18d4c7-9484-4d3e-b61b-e81fe63fefec | 7 |
| 1423080 | doxycycline hyclate 200 MG Delayed Release Oral Tablet | PSN | 0a18d4c7-9484-4d3e-b61b-e81fe63fefec | 7 |
| 1653433 | doxycycline hyclate 50 MG Delayed Release Oral Tablet | PSN | 0a18d4c7-9484-4d3e-b61b-e81fe63fefec | 7 |
| 799048 | doxycycline hyclate 150 MG Delayed Release Oral Tablet | SCD | 0a18d4c7-9484-4d3e-b61b-e81fe63fefec | 7 |
| 1423080 | doxycycline hyclate 200 MG Delayed Release Oral Tablet | SCD | 0a18d4c7-9484-4d3e-b61b-e81fe63fefec | 7 |
| 1653433 | doxycycline hyclate 50 MG Delayed Release Oral Tablet | SCD | 0a18d4c7-9484-4d3e-b61b-e81fe63fefec | 7 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 43547-462-12 | 43547046212 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (43547-462-12) | 2018-11-28 | 0000-00-00 | No | No | Current |