Doxycycline Hyclate

Product NDC
67296-1743
11-digit product format
672961743
Labeler code
67296
Product ID
67296-1743_d61ca7d2-1c87-214a-e053-2a95a90ae278
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA062396
Marketing category
ANDA
Marketing start
1984-05-07
Marketing end
0000-00-00
Substance
DOXYCYCLINE HYCLATE
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67296-1743IInactivated by FDA2026-10-05
excluded packagepackage67296-174367296-1743-2IInactivated by FDA2026-10-05
excluded packagepackage67296-174367296-1743-7IInactivated by FDA2026-10-05

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062396-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABRS1984-05-07
A062396-002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A062396-001AB
A062396-002AB

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABRS1984-05-0784e616aacf4f…
2026-09-14 22:38:342026-08A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-0784e616aacf4f…
2026-08-18 06:07:402026-07A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABRS1984-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABRS1984-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABRS1984-05-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABRS1984-05-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABRS1984-05-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-0774a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A062396-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A062396-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A062396-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A062396-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062396-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062396-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062396-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062396-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062396-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062396-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062396-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062396-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062396-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062396-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062396-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062396-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062396-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062396-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062396-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062396-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062396-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062396-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062396-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A062396-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062396-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062396-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062396-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062396-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062396-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062396-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062396-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062396-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062396-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062396-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062396-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062396-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062396-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062396-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062396-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062396-002AB174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

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

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
67296-1743-22026-01-29C16284748780-149896155-c539-586f-e063-e6dba90add90Doxycycline 100MG Hyclate Capsules
67296-1743-72026-01-29C16284748780-149896155-c539-586f-e063-e6dba90add90Doxycycline 100MG Hyclate Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1743-2Doxycycline Hyclate20 in 1 BOTTLECAPSULE204
67296-1743-7Doxycycline Hyclate14 in 1 BOTTLECAPSULE144

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1743DOXYCYCLINE HYCLATE CAPSULE [REDPHARM DRUG, INC.]4Legacy NDC, 2 package rows20240805_b336f235-5b57-7d6a-e053-2a95a90a0b88.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxycycline HyclateDOXYCYCLINE HYCLATEA-S Medication Solutions9ecadbc8-3087-4692-916a-b7f392d8e8da2026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycyclate HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.4dc319c1-b7ef-40e4-9e66-fb24cfdefea82026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEUnit Dose Solutions, Inc.548d4218-2feb-8716-e063-6394a90afbe32026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.e24a3292-0d4f-4692-8cf7-a82bd19e59322026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.5f523294-e62b-4da5-8799-047d4bed966f2026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATECoupler LLC52ba329a-8cb3-cf30-e063-6394a90aa0dc2026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.3a85933f-bd73-4ad7-968d-c90cb7c7a60c2026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATENorthwind Health Company, LLCf309ccbb-b68a-3190-e053-2995a90a0ad42026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEMajor Pharmaceuticalsc4aae81f-0219-450f-aa60-953964f741722025-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATENuCare Pharmaceuticals,Inc.8c525e4e-6e1b-4579-e053-2a95a90a43da2025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEAmerican Health Packaginge98d11b0-535f-4e57-9639-6358835c04bc2025-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEHikma Pharmaceuticals USA Inc.4ec4c8ca-ce83-4948-8626-21eb82ae5c192025-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATECoupler LLC325d5331-d48e-1bc4-e063-6394a90a65b92025-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
DoxycyclineDOXYCYCLINEDirect_Rx8c273efa-62ec-16b2-e053-2995a90ac41d2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEBryant Ranch Prepack214e5a5c-7f3e-478b-93d3-1713de9e76722024-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATENuCare Pharmaceuticals,Inc.88012cf8-509b-84cf-e053-2a95a90af3bc2024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSNb336f235-5b57-7d6a-e053-2a95a90a0b884
1649988doxycycline hyclate 100 MG Oral CapsuleSCDb336f235-5b57-7d6a-e053-2a95a90a0b884
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYb336f235-5b57-7d6a-e053-2a95a90a0b884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1743-26729617430220 CAPSULE in 1 BOTTLE (67296-1743-2) 20 capsule1984-05-070000-00-00NoNoCurrent
67296-1743-76729617430714 in 1 BOTTLEHistorical