DOXYCYCLINE

Product NDC
51655-711
11-digit product format
516550711
Labeler code
51655
Product ID
51655-711_4a7a4659-e98c-7bbe-e063-6394a90adc9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA204234
Marketing category
ANDA
Marketing start
2023-01-20
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 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
A204234-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-05
A204234-002DOXYCYCLINEDOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-05
A204234-003DOXYCYCLINEDOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204234-001AB
A204234-002AB
A204234-003AB

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 UTC2026-02A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-058072bd15b7f6…

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 UTC2026-02A204234-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204234-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204234-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204234-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204234-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204234-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204234-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204234-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204234-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204234-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204234-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204234-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204234-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204234-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204234-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204234-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204234-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204234-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204234-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204234-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204234-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204234-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204234-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204234-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204234-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204234-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204234-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204234-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204234-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204234-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204234-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204234-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204234-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204234-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204234-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204234-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204234-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204234-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204234-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204234-001AB18072bd15b7f6…

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.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOXYCYCLINEDOXYCYCLINEREMEDYREPACK INC.fa2d9328-b688-47af-8c4d-dc328cf353922026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204234
application number: ANDA204234
DOXYCYCLINEDOXYCYCLINENorthwind Health Company, LLCf3319f4f-b535-da12-e053-2995a90ac00f2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204234
application number: ANDA204234
ndc (product): 51655-711
DOXYCYCLINEDOXYCYCLINEProficient Rx LP00ea3641-18da-4a6f-a779-e16075464d2b2025-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204234
application number: ANDA204234
DOXYCYCLINEDOXYCYCLINELupin Pharmaceuticals, Inc.bcc65910-30d8-4807-ab61-607a563829242024-11-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204234
application number: ANDA204234

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
f3319f4f-b535-da12-e053-2995a90ac00fAvailable 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
51655-711-20DOXYCYCLINE20 in 1 BOTTLE, PLASTICCAPSULE203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-711DOXYCYCLINE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 1 package rows20240727_f3319f4f-b535-da12-e053-2995a90ac00f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSNf3319f4f-b535-da12-e053-2995a90ac00f3
1649990doxycycline monohydrate 100 MG Oral CapsuleSCDf3319f4f-b535-da12-e053-2995a90ac00f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-711-205165507112020 CAPSULE in 1 BOTTLE, PLASTIC (51655-711-20) 20 capsule2023-01-20NoNoCurrent