Doxycyclate Hyclate
- Product NDC
- 70518-1627
- Requested package NDC
- 70518-1627-0
- 11-digit product format
- 705181627
- Labeler code
- 70518
- Product ID
- 70518-1627_4ef85f00-9f10-c2c2-e063-6394a90a0716
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxycycline Hyclate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA062396
- Marketing category
- ANDA
- Marketing start
- 2018-11-02
- Substance
- DOXYCYCLINE HYCLATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Tetracycline-class Drug [EPC], Tetracyclines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-1627 | 70518-1627-0 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70518-1627 | 70518-1627-0 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70518-1627 | 70518-1627-0 | D | Discontinued by firm | excluded / ndc_excluded.zip | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70518-1627 | 70518-1627-0 | D | Discontinued by firm | excluded / ndc_excluded.zip | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70518-1627 | 70518-1627-0 | D | Discontinued by firm | excluded / ndc_excluded.zip | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70518-1627 | 70518-1627-0 | D | Discontinued by firm | excluded / ndc_excluded.zip | cdf11ea48f46… | ba0047e9e063… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70518-1627 | 70518-1627-0 | D | Discontinued by firm | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70518-1627 | 70518-1627-0 | D | Discontinued by firm | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70518-1627 | 70518-1627-0 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70518-1627 | 70518-1627-0 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70518-1627 | 70518-1627-0 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062396-001 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | RS | 1984-05-07 |
| A062396-002 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1984-11-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A062396-001 | AB |
| A062396-002 | 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 | A062396-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | RS | 1984-05-07 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A062396-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1984-11-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062396-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | RS | 1984-05-07 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062396-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1984-11-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A062396-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | RS | 1984-05-07 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A062396-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1984-11-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062396-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | RS | 1984-05-07 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062396-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1984-11-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062396-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1984-05-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062396-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1984-11-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062396-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1984-05-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062396-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1984-11-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062396-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1984-05-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062396-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1984-11-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062396-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1984-05-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062396-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1984-11-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062396-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1984-05-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062396-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1984-11-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A062396-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1984-05-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A062396-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1984-11-07 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062396-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1984-05-07 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062396-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1984-11-07 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062396-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1984-05-07 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062396-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1984-11-07 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062396-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1984-05-07 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062396-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1984-11-07 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A062396-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1984-05-07 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A062396-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1984-11-07 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062396-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1984-05-07 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062396-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1984-11-07 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A062396-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1984-05-07 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A062396-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1984-11-07 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A062396-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1984-05-07 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A062396-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1984-11-07 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A062396-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1984-05-07 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A062396-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1984-11-07 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A062396-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1984-05-07 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A062396-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1984-11-07 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A062396-001 | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1984-05-07 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A062396-002 | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1984-11-07 | 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 | A062396-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A062396-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062396-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062396-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A062396-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A062396-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062396-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062396-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062396-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062396-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062396-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062396-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062396-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062396-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062396-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062396-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062396-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062396-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A062396-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A062396-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062396-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062396-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062396-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062396-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062396-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062396-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A062396-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A062396-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062396-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062396-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A062396-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A062396-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A062396-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A062396-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A062396-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A062396-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A062396-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A062396-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A062396-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A062396-002 | AB | 1 | 782e0a99824c… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Doxycyclate Hyclate | DOXYCYCLINE HYCLATE | REMEDYREPACK INC. | 4dc319c1-b7ef-40e4-9e66-fb24cfdefea8 | 2026-07-09 | Warnings, Adverse reactions | 062396 ANDA062396 70518-1627-0 70518-1627 70518162700 |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Unit Dose Solutions, Inc. | 548d4218-2feb-8716-e063-6394a90afbe3 | 2026-06-18 | Warnings, Adverse reactions | 062396 ANDA062396 |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | PD-Rx Pharmaceuticals, Inc. | e24a3292-0d4f-4692-8cf7-a82bd19e5932 | 2026-06-08 | Warnings, Adverse reactions | 062396 ANDA062396 |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | PD-Rx Pharmaceuticals, Inc. | 5f523294-e62b-4da5-8799-047d4bed966f | 2026-06-04 | Warnings, Adverse reactions | 062396 ANDA062396 |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Coupler LLC | 52ba329a-8cb3-cf30-e063-6394a90aa0dc | 2026-05-26 | Warnings, Adverse reactions | 062396 ANDA062396 |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | REMEDYREPACK INC. | 3a85933f-bd73-4ad7-968d-c90cb7c7a60c | 2026-05-13 | Warnings, Adverse reactions | 062396 ANDA062396 |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Northwind Health Company, LLC | f309ccbb-b68a-3190-e053-2995a90a0ad4 | 2026-01-01 | Warnings, Adverse reactions | 062396 ANDA062396 |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Major Pharmaceuticals | c4aae81f-0219-450f-aa60-953964f74172 | 2025-12-23 | Warnings, Adverse reactions | 062396 ANDA062396 |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | NuCare Pharmaceuticals,Inc. | 8c525e4e-6e1b-4579-e053-2a95a90a43da | 2025-11-18 | Warnings, Adverse reactions | 062396 ANDA062396 |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | American Health Packaging | e98d11b0-535f-4e57-9639-6358835c04bc | 2025-11-13 | Warnings, Adverse reactions | 062396 ANDA062396 |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Hikma Pharmaceuticals USA Inc. | 4ec4c8ca-ce83-4948-8626-21eb82ae5c19 | 2025-10-28 | Warnings, Adverse reactions | 062396 ANDA062396 |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Coupler LLC | 325d5331-d48e-1bc4-e063-6394a90a65b9 | 2025-04-09 | Warnings, Adverse reactions | 062396 ANDA062396 |
| Doxycycline | DOXYCYCLINE | Direct_Rx | 8c273efa-62ec-16b2-e053-2995a90ac41d | 2025-01-22 | Warnings, Adverse reactions | 062396 ANDA062396 |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Bryant Ranch Prepack | 214e5a5c-7f3e-478b-93d3-1713de9e7672 | 2024-08-07 | Warnings, Adverse reactions | 062396 ANDA062396 |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | NuCare Pharmaceuticals,Inc. | 88012cf8-509b-84cf-e053-2a95a90af3bc | 2024-06-14 | Warnings, Adverse reactions | 062396 ANDA062396 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Doxycyclate Hyclate
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DOXYCYCLINE HYCLATE | 100 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 19XTS3T51U | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1649988 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4dc319c1-b7ef-40e4-9e66-fb24cfdefea8 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b4321c75-2e87-4d90-9726-9a28fb2293a3 | Product name | 3 | 20260112 |
| 5e99724e-0654-4aec-b7a2-0b9b10e312ee | Product name | 3 | 20250227 |
| d2d36660-68ce-7e7d-0630-ec4b0d859fad | Product name | 6 | 20220921 |
| a239f4dd-cf93-4660-b190-f97d000f249f | Product name | 7 | 20210607 |
| a9d03566-caeb-4466-8021-74599b048880 | Product name | 3 | 20210604 |
| 12750814-20f7-4f35-b5fa-dbc8811ba858 | Product name | 9 | 20201007 |
| 00a5dbaa-1b7d-4e56-be0c-fedc7bbf5ade | Product name | 1 | 20200706 |
| 7b4b06ac-8c50-45f0-9556-293ea558a294 | Product name | 1 | 20180808 |
| 6a5b4392-5ab0-af0d-e0be-47b34e9dbb84 | Product name | 5 | 20171121 |
| 01a4aa74-7e05-63bd-bc10-1b5ceb111371 | Product name | 2 | 20171115 |
| 58b1278c-6dce-49b6-a05e-ea16f389acba | Product name | 1 | 20160620 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70518-1627-0 | Doxycyclate Hyclate | 30 in 1 BLISTER PACK | CAPSULE | 30 | 25 | |
| 70518-1627-1 | Doxycyclate Hyclate | 20 in 1 BOTTLE, PLASTIC | CAPSULE | 20 | 25 | |
| 70518-1627-2 | Doxycyclate Hyclate | 180 in 1 BOTTLE, PLASTIC | CAPSULE | 180 | 25 | |
| 70518-1627-3 | Doxycyclate Hyclate | 20 in 1 BLISTER PACK | CAPSULE | 20 | 25 | |
| 70518-1627-4 | Doxycyclate Hyclate | 14 in 1 BOTTLE, PLASTIC | CAPSULE | 14 | 25 | |
| 70518-1627-5 | Doxycyclate Hyclate | 14 in 1 BOTTLE, PLASTIC | CAPSULE | 14 | 25 | |
| 70518-1627-6 | Doxycyclate Hyclate | 50 in 1 BOTTLE, PLASTIC | CAPSULE | 50 | 25 | |
| 70518-1627-7 | Doxycyclate Hyclate | 20 in 1 BOTTLE, PLASTIC | CAPSULE | 20 | 25 | |
| 70518-1627-8 | Doxycyclate Hyclate | 28 in 1 BOTTLE, PLASTIC | CAPSULE | 28 | 25 | |
| 70518-1627-9 | Doxycyclate Hyclate | 56 in 1 BOTTLE, PLASTIC | CAPSULE | 56 | 25 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-1627 | DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [REMEDYREPACK INC.] | 20 | Current NDC, Legacy NDC, 10 package rows | 20250215_4dc319c1-b7ef-40e4-9e66-fb24cfdefea8.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1649988 | doxycycline hyclate 100 MG Oral Capsule | PSN | 4dc319c1-b7ef-40e4-9e66-fb24cfdefea8 | 25 |
| 1649988 | doxycycline hyclate 100 MG Oral Capsule | SCD | 4dc319c1-b7ef-40e4-9e66-fb24cfdefea8 | 25 |
| 1649988 | doxycycline (as doxycycline hyclate) 100 MG Oral Capsule | SY | 4dc319c1-b7ef-40e4-9e66-fb24cfdefea8 | 25 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-1627-0 | 70518162700 | 30 CAPSULE in 1 BLISTER PACK (70518-1627-0) | 30 capsule | 2018-11-02 | 0000-00-00 | No | No | Current |