Doxycycline

Product NDC
71335-3064
Requested package NDC
71335-3064-8
11-digit product format
713353064
Labeler code
71335
Product ID
71335-3064_6abca45c-7c23-4c1b-994e-f36b42e98a0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA065055
Marketing category
ANDA
Marketing start
2022-08-01
Substance
DOXYCYCLINE
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-0184e616aacf4f…
2026-09-14 22:38:342026-08A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-0184e616aacf4f…
2026-09-14 22:38:342026-08A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-1584e616aacf4f…
2026-09-14 22:38:342026-08A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-1884e616aacf4f…
2026-08-18 06:07:402026-07A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01caaa826d4ba7…
2026-08-18 06:07:402026-07A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01caaa826d4ba7…
2026-08-18 06:07:402026-07A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A065055-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A065055-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A065055-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A065055-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065055-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065055-003AB1caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Doxycycline
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N12000U13OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1649990Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6285181d-e34d-4def-abe6-2c41254ada75Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b4321c75-2e87-4d90-9726-9a28fb2293a3Product name320260112
5e99724e-0654-4aec-b7a2-0b9b10e312eeProduct name320250227
d2d36660-68ce-7e7d-0630-ec4b0d859fadProduct name620220921
a239f4dd-cf93-4660-b190-f97d000f249fProduct name720210607
a9d03566-caeb-4466-8021-74599b048880Product name320210604
12750814-20f7-4f35-b5fa-dbc8811ba858Product name920201007
00a5dbaa-1b7d-4e56-be0c-fedc7bbf5adeProduct name120200706
7b4b06ac-8c50-45f0-9556-293ea558a294Product name120180808
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84Product name520171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371Product name220171115
58b1278c-6dce-49b6-a05e-ea16f389acbaProduct name120160620

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-3064-0Doxycycline2 in 1 BOTTLECAPSULE21
71335-3064-1Doxycycline30 in 1 BOTTLECAPSULE301
71335-3064-2Doxycycline14 in 1 BOTTLECAPSULE141
71335-3064-3Doxycycline20 in 1 BOTTLECAPSULE201
71335-3064-4Doxycycline12 in 1 BOTTLECAPSULE121
71335-3064-5Doxycycline40 in 1 BOTTLECAPSULE401
71335-3064-6Doxycycline10 in 1 BOTTLECAPSULE101
71335-3064-7Doxycycline50 in 1 BOTTLECAPSULE501
71335-3064-8Doxycycline21 in 1 BOTTLECAPSULE211
71335-3064-9Doxycycline60 in 1 BOTTLECAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-3064-0EA - Each71335-306420e89d97-3f3e-4399-91d7-99ad6edde43b12026-03-17
71335-3064-1EA - Each71335-3064bb6c567b-0b29-437b-9f4e-1328faabe3a012026-03-17
71335-3064-2EA - Each71335-3064ce240c4e-694c-4895-a27b-f49ad0acfd3712026-03-17
71335-3064-3EA - Each71335-3064ed56a29b-b447-4990-a8ee-9ee08340e17c12026-03-17
71335-3064-4EA - Each71335-30641899e9e5-1fed-4af4-994e-6317772a16e812026-03-17
71335-3064-5EA - Each71335-3064e2e626cc-a5f4-4f3e-8036-e2940d1ba89612026-03-17
71335-3064-6EA - Each71335-30641200d070-899e-450d-bd14-8e712545785812026-03-17
71335-3064-7EA - Each71335-3064593c7b7c-b6d7-4907-84f5-e8fb2555786112026-03-17
71335-3064-8EA - Each71335-306411fa12ba-41a3-41f3-8a0f-b52beabe4bfd12026-03-17
71335-3064-9EA - Each71335-30644382d037-7259-423e-86e7-eafa836aa48a12026-03-17

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
ndc (package): 71335-3064-8
ndc (product): 71335-3064
ndc11 (package): 71335306408
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSN6285181d-e34d-4def-abe6-2c41254ada751
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD6285181d-e34d-4def-abe6-2c41254ada751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3064-87133530640821 CAPSULE in 1 BOTTLE (71335-3064-8) 21 capsule2026-02-06NoNoCurrent