Doxycycline

Product NDC
70518-0187
Requested package NDC
70518-0187-1
11-digit product format
705180187
Labeler code
70518
Product ID
70518-0187_df62c3c8-ab97-2b7f-e053-2a95a90a1caa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA065055
Marketing category
ANDA
Marketing start
2017-01-31
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
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.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-018770518-0187-1DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065055-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01
A065055-002DOXYCYCLINEDOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01
A065055-003DOXYCYCLINEDOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15
A065055-004DOXYCYCLINEDOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A065055-001AB
A065055-002AB
A065055-003AB

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.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065055-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065055-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065055-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065055-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065055-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065055-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065055-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065055-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065055-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065055-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065055-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065055-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065055-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065055-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065055-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065055-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065055-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065055-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065055-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065055-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065055-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065055-001AB18072bd15b7f6…

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.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINEBryant Ranch Prepack04de98f3-33a2-48ba-85b5-9fac867524b72026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEGolden State Medical Supply, Inc.e9997efa-9ad8-3870-e053-2a95a90a1ac32026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEStrides Pharma Science Limited9e710113-f25e-46fb-8327-7a8e649613a22026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEAmerican Health Packaginge49f8ff9-af7a-47eb-929b-238cff381c032026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEAmerican Health Packaging3fbf4bb8-036e-41d3-9628-476fc05ddd312026-02-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEBryant Ranch Prepack6285181d-e34d-4def-abe6-2c41254ada752026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEStrides Pharma Science Limitedd27c58a1-5c99-4007-9bc6-ad9b6fb56db82025-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINENuCare Pharmaceuticals,Inc.fa1da527-7a0f-8ed6-e053-6394a90a1b622024-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEProficient Rx LPc707566b-dbc7-4dac-bad1-952f2f4d68452024-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEA-S Medication Solutions6aab6fee-791e-4141-b55f-685ec9d8712a2023-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0187-17051801870114 CAPSULE in 1 BOTTLE, PLASTIC (70518-0187-1) 14 capsule2017-03-020000-00-00NoNoCurrent