Doxycycline

Product NDC
71335-1988
11-digit product format
713351988
Labeler code
71335
Product ID
71335-1988_7718eba1-147a-405e-8846-473007eac7b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA065053
Marketing category
ANDA
Marketing start
2000-12-26
Substance
DOXYCYCLINE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065053-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-22
A065053-002DOXYCYCLINEDOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-22
A065053-003DOXYCYCLINEDOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065053-001AB
A065053-002AB
A065053-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-228072bd15b7f6…

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 UTC2026-02A065053-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065053-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065053-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065053-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065053-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065053-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065053-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065053-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065053-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065053-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065053-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065053-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065053-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065053-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065053-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065053-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065053-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065053-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065053-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065053-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065053-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065053-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065053-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065053-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065053-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065053-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065053-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065053-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065053-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065053-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065053-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065053-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065053-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065053-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065053-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065053-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065053-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065053-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065053-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065053-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Doxycycline
Listing expiration
2026-12-31

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
4b170180-21f4-4ee5-9e81-1607ab52cfcaAvailable 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
71335-1988-0Doxycycline2 in 1 BOTTLECAPSULE2102
71335-1988-1Doxycycline30 in 1 BOTTLECAPSULE30102
71335-1988-2Doxycycline14 in 1 BOTTLECAPSULE14102
71335-1988-3Doxycycline20 in 1 BOTTLECAPSULE20102
71335-1988-4Doxycycline12 in 1 BOTTLECAPSULE12102
71335-1988-5Doxycycline40 in 1 BOTTLECAPSULE40102
71335-1988-6Doxycycline10 in 1 BOTTLECAPSULE10102
71335-1988-7Doxycycline50 in 1 BOTTLECAPSULE50102
71335-1988-8Doxycycline21 in 1 BOTTLECAPSULE21102
71335-1988-9Doxycycline60 in 1 BOTTLECAPSULE60102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1988DOXYCYCLINE CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 10 package rows20240726_4b170180-21f4-4ee5-9e81-1607ab52cfca.zip

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINESun Pharmaceutical Industries, Inc.829dbd3d-5c2b-47b8-96a5-423af78c93b92025-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065053
application number: ANDA065053
Doxycycline MonohydrateDOXYCYCLINE MONOHYDRATEDirect_Rxdfef600c-bceb-fbc9-e053-2a95a90ae6c02025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065053
application number: ANDA065053
DoxycyclineDOXYCYCLINEBryant Ranch Prepack4b170180-21f4-4ee5-9e81-1607ab52cfca2024-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065053
application number: ANDA065053
ndc (product): 71335-1988

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSN4b170180-21f4-4ee5-9e81-1607ab52cfca102
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD4b170180-21f4-4ee5-9e81-1607ab52cfca102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1988-0713351988002 CAPSULE in 1 BOTTLE (71335-1988-0) 2 capsule2022-03-100000-00-00NoNoCurrent
71335-1988-17133519880130 CAPSULE in 1 BOTTLE (71335-1988-1) 30 capsule2022-03-110000-00-00NoNoCurrent
71335-1988-27133519880214 CAPSULE in 1 BOTTLE (71335-1988-2) 14 capsule2022-03-100000-00-00NoNoCurrent
71335-1988-37133519880320 CAPSULE in 1 BOTTLE (71335-1988-3) 20 capsule2021-11-110000-00-00NoNoCurrent
71335-1988-47133519880412 CAPSULE in 1 BOTTLE (71335-1988-4) 12 capsule2024-07-180000-00-00NoNoCurrent
71335-1988-57133519880540 CAPSULE in 1 BOTTLE (71335-1988-5) 40 capsule2024-07-180000-00-00NoNoCurrent
71335-1988-67133519880610 CAPSULE in 1 BOTTLE (71335-1988-6) 10 capsule2024-07-180000-00-00NoNoCurrent
71335-1988-77133519880750 CAPSULE in 1 BOTTLE (71335-1988-7) 50 capsule2024-07-180000-00-00NoNoCurrent
71335-1988-87133519880821 CAPSULE in 1 BOTTLE (71335-1988-8) 21 capsule2024-07-180000-00-00NoNoCurrent
71335-1988-97133519880960 CAPSULE in 1 BOTTLE (71335-1988-9) 60 capsule2024-07-180000-00-00NoNoCurrent