Doxycycline
- Product NDC
- 63187-135
- 11-digit product format
- 631870135
- Labeler code
- 63187
- Product ID
- 63187-135_305c2440-855c-4b18-b542-75ae99e2deee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- doxycycline
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA065055
- Marketing category
- ANDA
- Marketing start
- 2000-12-01
- Marketing end
- 0000-00-00
- Substance
- DOXYCYCLINE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Tetracycline-class Drug [EPC],Tetracyclines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 63187-135 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 63187-135 | 63187-135-14 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 63187-135 | 63187-135-20 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 63187-135 | 63187-135-30 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065055-001 | DOXYCYCLINE | DOXYCYCLINE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-12-01 | |
| A065055-002 | DOXYCYCLINE | DOXYCYCLINE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2000-12-01 | |
| A065055-003 | DOXYCYCLINE | DOXYCYCLINE | EQ 150MG BASE | CAPSULE / ORAL | AB | RS | 2005-07-15 |
| A065055-004 | DOXYCYCLINE | DOXYCYCLINE | EQ 75MG BASE | CAPSULE / ORAL | 2005-04-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065055-001 | AB |
| A065055-002 | AB |
| A065055-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065055-001 | DOXYCYCLINE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-12-01 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065055-002 | DOXYCYCLINE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2000-12-01 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065055-003 | DOXYCYCLINE | EQ 150MG BASE | CAPSULE / ORAL | AB | RS | 2005-07-15 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065055-004 | DOXYCYCLINE | EQ 75MG BASE | CAPSULE / ORAL | 2005-04-18 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065055-001 | DOXYCYCLINE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-12-01 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065055-002 | DOXYCYCLINE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2000-12-01 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065055-003 | DOXYCYCLINE | EQ 150MG BASE | CAPSULE / ORAL | AB | RS | 2005-07-15 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065055-004 | DOXYCYCLINE | EQ 75MG BASE | CAPSULE / ORAL | 2005-04-18 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065055-001 | DOXYCYCLINE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-12-01 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065055-002 | DOXYCYCLINE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2000-12-01 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065055-003 | DOXYCYCLINE | EQ 150MG BASE | CAPSULE / ORAL | AB | RS | 2005-07-15 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065055-004 | DOXYCYCLINE | EQ 75MG BASE | CAPSULE / ORAL | 2005-04-18 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A065055-001 | DOXYCYCLINE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-12-01 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | A065055-002 | DOXYCYCLINE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2000-12-01 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | A065055-003 | DOXYCYCLINE | EQ 150MG BASE | CAPSULE / ORAL | AB | RS | 2005-07-15 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A065055-004 | DOXYCYCLINE | EQ 75MG BASE | CAPSULE / ORAL | 2005-04-18 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A065055-001 | DOXYCYCLINE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-12-01 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | A065055-002 | DOXYCYCLINE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2000-12-01 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | A065055-003 | DOXYCYCLINE | EQ 150MG BASE | CAPSULE / ORAL | AB | RS | 2005-07-15 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A065055-004 | DOXYCYCLINE | EQ 75MG BASE | CAPSULE / ORAL | 2005-04-18 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065055-001 | DOXYCYCLINE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-12-01 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065055-002 | DOXYCYCLINE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2000-12-01 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065055-003 | DOXYCYCLINE | EQ 150MG BASE | CAPSULE / ORAL | AB | RS | 2005-07-15 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065055-004 | DOXYCYCLINE | EQ 75MG BASE | CAPSULE / ORAL | 2005-04-18 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A065055-001 | DOXYCYCLINE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-12-01 | f41ea6bd6efb… | |
| 2022-10-28 04:53 UTC | 2022-10 | A065055-002 | DOXYCYCLINE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2000-12-01 | f41ea6bd6efb… | |
| 2022-10-28 04:53 UTC | 2022-10 | A065055-003 | DOXYCYCLINE | EQ 150MG BASE | CAPSULE / ORAL | AB | RS | 2005-07-15 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A065055-004 | DOXYCYCLINE | EQ 75MG BASE | CAPSULE / ORAL | 2005-04-18 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A065055-001 | DOXYCYCLINE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-12-01 | e64feba35796… | |
| 2022-09-29 23:25 UTC | 2022-09 | A065055-002 | DOXYCYCLINE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2000-12-01 | e64feba35796… | |
| 2022-09-29 23:25 UTC | 2022-09 | A065055-003 | DOXYCYCLINE | EQ 150MG BASE | CAPSULE / ORAL | AB | RS | 2005-07-15 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A065055-004 | DOXYCYCLINE | EQ 75MG BASE | CAPSULE / ORAL | 2005-04-18 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A065055-001 | DOXYCYCLINE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-12-01 | cb3db0bc1861… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A065055-002 | DOXYCYCLINE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2000-12-01 | cb3db0bc1861… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A065055-003 | DOXYCYCLINE | EQ 150MG BASE | CAPSULE / ORAL | AB | RS | 2005-07-15 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A065055-004 | DOXYCYCLINE | EQ 75MG BASE | CAPSULE / ORAL | 2005-04-18 | cb3db0bc1861… | ||
| 2026-08-01 22:54:32 | 2026-06 | A065055-001 | DOXYCYCLINE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-12-01 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A065055-002 | DOXYCYCLINE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2000-12-01 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A065055-003 | DOXYCYCLINE | EQ 150MG BASE | CAPSULE / ORAL | AB | RS | 2005-07-15 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A065055-004 | DOXYCYCLINE | EQ 75MG BASE | CAPSULE / ORAL | 2005-04-18 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065055-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065055-002 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065055-003 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065055-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065055-002 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065055-003 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065055-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065055-002 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065055-003 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A065055-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A065055-002 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A065055-003 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A065055-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A065055-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A065055-003 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065055-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065055-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065055-003 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A065055-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A065055-002 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A065055-003 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A065055-001 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A065055-002 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A065055-003 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A065055-001 | AB | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A065055-002 | AB | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A065055-003 | AB | 1 | cb3db0bc1861… |
| 2026-08-01 22:54:32 | 2026-06 | A065055-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A065055-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A065055-003 | AB | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Doxycycline | DOXYCYCLINE | Bryant Ranch Prepack | 04de98f3-33a2-48ba-85b5-9fac867524b7 | 2026-07-15 | Warnings, Adverse reactions | 065055 ANDA065055 |
| Doxycycline | DOXYCYCLINE | Golden State Medical Supply, Inc. | e9997efa-9ad8-3870-e053-2a95a90a1ac3 | 2026-07-06 | Warnings, Adverse reactions | 065055 ANDA065055 |
| Doxycycline | DOXYCYCLINE | Strides Pharma Science Limited | 9e710113-f25e-46fb-8327-7a8e649613a2 | 2026-06-10 | Warnings, Adverse reactions | 065055 ANDA065055 |
| Doxycycline | DOXYCYCLINE | American Health Packaging | e49f8ff9-af7a-47eb-929b-238cff381c03 | 2026-04-29 | Warnings, Adverse reactions | 065055 ANDA065055 |
| Doxycycline | DOXYCYCLINE | American Health Packaging | 3fbf4bb8-036e-41d3-9628-476fc05ddd31 | 2026-02-23 | Warnings, Adverse reactions | 065055 ANDA065055 |
| Doxycycline | DOXYCYCLINE | Bryant Ranch Prepack | 6285181d-e34d-4def-abe6-2c41254ada75 | 2026-02-06 | Warnings, Adverse reactions | 065055 ANDA065055 |
| Doxycycline | DOXYCYCLINE | Strides Pharma Science Limited | d27c58a1-5c99-4007-9bc6-ad9b6fb56db8 | 2025-09-03 | Warnings, Adverse reactions | 065055 ANDA065055 |
| Doxycycline | DOXYCYCLINE | NuCare Pharmaceuticals,Inc. | fa1da527-7a0f-8ed6-e053-6394a90a1b62 | 2024-02-09 | Warnings, Adverse reactions | 065055 ANDA065055 |
| Doxycycline | DOXYCYCLINE | Proficient Rx LP | c707566b-dbc7-4dac-bad1-952f2f4d6845 | 2024-02-01 | Warnings, Adverse reactions | 065055 ANDA065055 |
| Doxycycline | DOXYCYCLINE | A-S Medication Solutions | 6aab6fee-791e-4141-b55f-685ec9d8712a | 2023-11-01 | Warnings, Adverse reactions | 065055 ANDA065055 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63187-135-20 | EA - Each | 63187-135 | 0bd2c61d-f594-4f61-9bd7-273862bbd470 | 1 | 2015-12-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| DOXYCYCLINE | ACTIVE INGREDIENT | N12000U13O | DOXYCYCLINE CAPSULE [PROFICIENT RX LP] | 4 | |
| DOXYCYCLINE ANHYDROUS | ACTIVE MOIETY | 334895S862 | DOXYCYCLINE CAPSULE [PROFICIENT RX LP] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DOXYCYCLINE CAPSULE [PROFICIENT RX LP] | 4 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | DOXYCYCLINE CAPSULE [PROFICIENT RX LP] | 4 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DOXYCYCLINE CAPSULE [PROFICIENT RX LP] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DOXYCYCLINE CAPSULE [PROFICIENT RX LP] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DOXYCYCLINE CAPSULE [PROFICIENT RX LP] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | DOXYCYCLINE CAPSULE [PROFICIENT RX LP] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DOXYCYCLINE CAPSULE [PROFICIENT RX LP] | 4 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63187-135-14 | 63187013514 | 14 CAPSULE in 1 BOTTLE (63187-135-14) | 14 capsule | 2019-01-01 | 0000-00-00 | No | No | Current |
| 63187-135-20 | 63187013520 | 20 CAPSULE in 1 BOTTLE (63187-135-20) | 20 capsule | 2019-01-01 | 0000-00-00 | No | No | Current |
| 63187-135-30 | 63187013530 | 30 CAPSULE in 1 BOTTLE (63187-135-30) | 30 capsule | 2019-01-01 | 0000-00-00 | No | No | Current |