Doxycycline Hyclate

Product NDC
80425-0211
11-digit product format
804250211
Labeler code
80425
Product ID
80425-0211_2a99c981-daf7-71e5-e063-6294a90a5c1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA062676
Marketing category
ANDA
Marketing start
2022-11-04
Substance
DOXYCYCLINE HYCLATE
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062676-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1986-07-10
A062676-002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1986-07-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062676-001AB
A062676-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A062676-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1986-07-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062676-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1986-07-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062676-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1986-07-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062676-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1986-07-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A062676-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1986-07-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062676-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1986-07-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062676-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1986-07-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062676-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1986-07-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062676-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1986-07-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062676-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1986-07-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062676-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1986-07-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062676-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1986-07-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062676-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1986-07-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062676-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1986-07-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062676-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1986-07-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062676-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1986-07-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062676-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1986-07-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062676-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1986-07-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062676-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1986-07-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A062676-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1986-07-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062676-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1986-07-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062676-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1986-07-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062676-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1986-07-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062676-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1986-07-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062676-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1986-07-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062676-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1986-07-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062676-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1986-07-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062676-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1986-07-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062676-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1986-07-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062676-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1986-07-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062676-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1986-07-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062676-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1986-07-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062676-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1986-07-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062676-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1986-07-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062676-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1986-07-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062676-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1986-07-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062676-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1986-07-10bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062676-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1986-07-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062676-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1986-07-10782e0a99824c…
2021-12-28 21:50 UTC2021-12A062676-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1986-07-10782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A062676-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062676-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062676-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062676-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062676-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062676-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062676-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062676-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062676-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062676-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062676-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062676-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062676-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062676-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062676-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062676-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062676-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062676-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062676-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A062676-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062676-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062676-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062676-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062676-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062676-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062676-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062676-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062676-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062676-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062676-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062676-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062676-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062676-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062676-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062676-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062676-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062676-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062676-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062676-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A062676-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
19XTS3T51UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1649988Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ecab47ea-d7b9-515d-e053-2995a90adc46Available 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
80425-0211-1Doxycycline Hyclate20 in 1 BOTTLECAPSULE206
80425-0211-2Doxycycline Hyclate10 in 1 BOTTLECAPSULE106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0211-1EA - Each80425-02115386f4e5-9990-4191-93dd-f66691f0e8e012023-04-07
80425-0211-2EA - Each80425-0211c91c1609-8501-4011-9c3b-6d295931176512023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0211DOXYCYCLINE HYCLATE CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 2 package rows20250101_ecab47ea-d7b9-515d-e053-2995a90adc46.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.0994d23a-f9e4-4c33-ba44-a1f4ae4a312c2026-07-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062676
application number: ANDA062676
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.b988f851-cc06-4570-9706-cf65d370bd8e2026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062676
application number: ANDA062676
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.35aa295e-ff1b-453b-8eeb-65bbeda3baa52026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062676
application number: ANDA062676
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.6e3d0691-c071-441c-9b00-22a3803050662026-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062676
application number: ANDA062676
Doxycycline HyclateDOXYCYCLINE HYCLATESun Pharmaceutical Industries, Inc.214a9cfe-a522-4022-81d4-e59f447401fe2026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062676
application number: ANDA062676
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEDIRECT RX9798c4de-8af7-41c4-acc2-1e97751942972026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062676
application number: ANDA062676
Doxycycline HyclateDOXYCYCLINE HYCLATEAvPAK53ff9f7e-0db0-c841-d334-4cf31f6588282025-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062676
application number: ANDA062676
Doxycycline HyclateDOXYCYCLINE HYCLATEAdvanced Rx Pharmacy of Tennessee, LLCecab47ea-d7b9-515d-e053-2995a90adc462024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062676
application number: ANDA062676
ndc (product): 80425-0211
Doxycycline HyclateDOXYCYCLINE HYCLATEAdvanced Rx Pharmacy of Tennessee, LLCf5ed9293-15f8-ecfa-e053-2a95a90ab6a42024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062676
application number: ANDA062676
Doxycycline HyclateDOXYCYCLINE HYCLATEQuality Care Products, LLC2a3b79e8-f14c-4b44-9d3e-3c92a82269bd2024-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062676
application number: ANDA062676
Doxycycline HyclateDOXYCYCLINE HYCLATENuCare Pharmaceuticals,Inc.0fdc3d87-8819-4c2c-e063-6394a90a687b2024-01-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062676
application number: ANDA062676
Doxycycline HyclateDOXYCYCLINE HYCLATEProficient Rx LP86c1f165-af79-4f01-ab61-3bdbce24cd0d2022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062676
application number: ANDA062676

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSNecab47ea-d7b9-515d-e053-2995a90adc466
1649988doxycycline hyclate 100 MG Oral CapsuleSCDecab47ea-d7b9-515d-e053-2995a90adc466
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYecab47ea-d7b9-515d-e053-2995a90adc466

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0211-18042502110120 CAPSULE in 1 BOTTLE (80425-0211-1) 20 capsule2023-11-04NoNoCurrent
80425-0211-28042502110210 CAPSULE in 1 BOTTLE (80425-0211-2) 10 capsule2023-11-04NoNoCurrent