doxycycline

Product NDC
67296-1385
11-digit product format
672961385
Labeler code
67296
Product ID
67296-1385_d61b7442-a7fb-62c4-e053-2a95a90ad9b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA205115
Marketing category
ANDA
Marketing start
2016-03-14
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#

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.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67296-1385IInactivated by FDA2026-08-03
excluded packagepackage67296-138567296-1385-1IInactivated by FDA2026-08-03
excluded packagepackage67296-138567296-1385-2IInactivated by FDA2026-08-03
excluded packagepackage67296-138567296-1385-3IInactivated by FDA2026-08-03
excluded packagepackage67296-138567296-1385-4IInactivated by FDA2026-08-03
excluded packagepackage67296-138567296-1385-5IInactivated by FDA2026-08-03

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
A205115-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-18
A205115-002DOXYCYCLINEDOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-18
A205115-003DOXYCYCLINEDOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205115-001AB
A205115-002AB
A205115-003AB

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 UTC2026-02A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-188072bd15b7f6…

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 UTC2026-02A205115-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205115-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205115-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205115-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205115-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205115-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205115-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205115-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205115-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205115-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205115-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205115-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205115-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205115-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205115-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205115-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205115-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205115-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205115-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205115-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205115-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205115-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205115-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205115-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205115-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205115-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205115-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205115-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205115-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205115-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205115-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205115-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205115-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205115-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205115-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205115-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205115-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205115-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205115-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205115-001AB18072bd15b7f6…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
doxycyclineDOXYCYCLINEPD-Rx Pharmaceuticals, Inc.7028b7f9-21cd-4c8e-97aa-a3e7d849939b2026-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
doxycyclineDOXYCYCLINEPD-Rx Pharmaceuticals, Inc.dedebcb4-3c3f-4487-a488-36af12640c922026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
DOXYCYCLINEDOXYCYCLINEDIRECT RX31512ece-cb16-2a9a-e054-00144ff88e882026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
doxycyclineDOXYCYCLINEA-S Medication Solutions2c7795c9-9e4e-477a-ad9f-01e4c55c06b62026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
doxycyclineDOXYCYCLINEAvPAKa5b28a41-db12-af7c-e053-2995a90ace092026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
doxycyclineDOXYCYCLINEZydus Pharmaceuticals USA Inc.fef9580d-8850-4cbb-89eb-2b4d40ee59c92025-04-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
doxycyclineDOXYCYCLINEZydus Lifesciences Limitedaa01035d-8b4a-4fdc-bfdf-2b39df0d8fc92024-11-28Exact identifier
application applno (ANDA): 205115
application number: ANDA205115
doxycyclineDOXYCYCLINEBryant Ranch Prepack5f989cc1-48ae-41bb-b297-2f8c83760b6d2024-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
doxycyclineDOXYCYCLINEProficient Rx LPf3ba6c30-ada3-4a57-9ff8-30558202b9aa2019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1385-12026-01-29C16284748780-11030e365-6053-111a-e063-dadaa90a10e2505b4f4f-ba7c-339d-e054-00144ff88e88
67296-1385-22026-01-29C16284748780-11030e365-6053-111a-e063-dadaa90a10e2505b4f4f-ba7c-339d-e054-00144ff88e88
67296-1385-32026-01-29C16284748780-11030e365-6053-111a-e063-dadaa90a10e2505b4f4f-ba7c-339d-e054-00144ff88e88
67296-1385-42026-01-29C16284748780-11030e365-6053-111a-e063-dadaa90a10e2505b4f4f-ba7c-339d-e054-00144ff88e88
67296-1385-52026-01-29C16284748780-11030e365-6053-111a-e063-dadaa90a10e2505b4f4f-ba7c-339d-e054-00144ff88e88
67296-1385-12024-08-07C16284748780-11030e365-6053-111a-e063-dadaa90a10e2505b4f4f-ba7c-339d-e054-00144ff88e88
67296-1385-22024-08-07C16284748780-11030e365-6053-111a-e063-dadaa90a10e2505b4f4f-ba7c-339d-e054-00144ff88e88
67296-1385-32024-08-07C16284748780-11030e365-6053-111a-e063-dadaa90a10e2505b4f4f-ba7c-339d-e054-00144ff88e88
67296-1385-42024-08-07C16284748780-11030e365-6053-111a-e063-dadaa90a10e2505b4f4f-ba7c-339d-e054-00144ff88e88
67296-1385-52024-08-07C16284748780-11030e365-6053-111a-e063-dadaa90a10e2505b4f4f-ba7c-339d-e054-00144ff88e88
67296-1385-12024-01-30C16284748780-11030e365-6053-111a-e063-dadaa90a10e2505b4f4f-ba7c-339d-e054-00144ff88e88
67296-1385-22024-01-30C16284748780-11030e365-6053-111a-e063-dadaa90a10e2505b4f4f-ba7c-339d-e054-00144ff88e88
67296-1385-32024-01-30C16284748780-11030e365-6053-111a-e063-dadaa90a10e2505b4f4f-ba7c-339d-e054-00144ff88e88
67296-1385-42024-01-30C16284748780-11030e365-6053-111a-e063-dadaa90a10e2505b4f4f-ba7c-339d-e054-00144ff88e88
67296-1385-52024-01-30C16284748780-11030e365-6053-111a-e063-dadaa90a10e2505b4f4f-ba7c-339d-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1385-1doxycycline14 in 1 BOTTLECAPSULE147
67296-1385-2doxycycline20 in 1 BOTTLECAPSULE207
67296-1385-3doxycycline28 in 1 BOTTLECAPSULE287
67296-1385-4doxycycline2 in 1 BOTTLECAPSULE27
67296-1385-5doxycycline42 in 1 BOTTLECAPSULE427

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1385DOXYCYCLINE CAPSULE [REDPHARM DRUG, INC.]7Legacy NDC, 5 package rows20240808_505b4f4f-ba7c-339d-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSN505b4f4f-ba7c-339d-e054-00144ff88e887
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD505b4f4f-ba7c-339d-e054-00144ff88e887

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1385-16729613850114 CAPSULE in 1 BOTTLE (67296-1385-1) 14 capsule2016-03-140000-00-00NoNoCurrent
67296-1385-26729613850220 CAPSULE in 1 BOTTLE (67296-1385-2) 20 capsule2016-03-140000-00-00NoNoCurrent
67296-1385-36729613850328 CAPSULE in 1 BOTTLE (67296-1385-3) 28 capsule2016-03-140000-00-00NoNoCurrent
67296-1385-4672961385042 CAPSULE in 1 BOTTLE (67296-1385-4) 2 capsule2016-03-140000-00-00NoNoCurrent
67296-1385-56729613850542 CAPSULE in 1 BOTTLE (67296-1385-5) 42 capsule2016-03-140000-00-00NoNoCurrent