Doxycycline Hyclate

Product NDC
53489-120
11-digit product format
534890120
Labeler code
53489
Product ID
53489-120_3309ec4b-fda9-8b52-e063-6394a90a5e18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA062677
Marketing category
ANDA
Marketing start
1986-07-10
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53489-12053489-120-60DDiscontinued by firm2026-08-10

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062677-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062677-001AB

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-103f01610625f2…
2019-09-15 20:21 UTC2019-09A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A062677-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062677-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062677-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062677-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062677-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062677-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062677-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062677-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062677-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062677-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062677-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062677-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062677-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062677-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062677-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062677-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062677-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062677-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062677-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062677-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062677-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A062677-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062677-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062677-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062677-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A062677-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A062677-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062677-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062677-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062677-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062677-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062677-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062677-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062677-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A062677-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A062677-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062677-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062677-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062677-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062677-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Doxycycline Hyclate
Listing expiration
2027-12-31

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1649405Internal RxNorm lookup
1649988Internal RxNorm lookup
1650143Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
214a9cfe-a522-4022-81d4-e59f447401feAvailable 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
53489-120-01Doxycycline Hyclate100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10023
53489-120-02Doxycycline Hyclate50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5023
53489-120-05Doxycycline Hyclate500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50023
53489-120-60Doxycycline Hyclate20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53489-120-01EA - Each53489-120bab822de-e534-483d-bf69-0926a4fd193d12024-01-04
53489-120-02EA - Each53489-120800bf49f-6b77-444b-90d3-e0860edf452812012-07-24
53489-120-05EA - Each53489-12057e34457-2cab-4ca4-b1c7-35e9c8984ccb12012-07-24
53489-120-60EA - Each53489-120ae552f93-9598-4a53-905b-62fc9e1ae5bf12024-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Doxycycline HyclateACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
Doxycycline AnhydrousACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
carnauba waxINACTIVE INGREDIENTR12CBM0EIZDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
D&C Red No. 28INACTIVE INGREDIENT767IP0Y5NHDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOADOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
gelatinINACTIVE INGREDIENT2G86QN327LDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
hypromellosesINACTIVE INGREDIENT3NXW29V3WODOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
magnesium stearateINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
Doxycycline HyclateACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
Doxycycline AnhydrousACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
carnauba waxINACTIVE INGREDIENTR12CBM0EIZDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOADOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
hypromellosesINACTIVE INGREDIENT3NXW29V3WODOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
magnesium stearateINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
Doxycycline HyclateACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
Doxycycline HyclateACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Doxycycline AnhydrousACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Doxycycline AnhydrousACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
carnauba waxINACTIVE INGREDIENTR12CBM0EIZDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
carnauba waxINACTIVE INGREDIENTR12CBM0EIZDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
D&C Red No. 28INACTIVE INGREDIENT767IP0Y5NHDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOADOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOADOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
gelatinINACTIVE INGREDIENT2G86QN327LDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WODOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WODOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
magnesium stearateINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
magnesium stearateINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Doxycycline HyclateACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
Doxycycline HyclateACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
Doxycycline AnhydrousACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
Doxycycline AnhydrousACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
D&C Red No. 28INACTIVE INGREDIENT767IP0Y5NHDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
D&C Red No. 28INACTIVE INGREDIENT767IP0Y5NHDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOADOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOADOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
gelatinINACTIVE INGREDIENT2G86QN327LDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
gelatinINACTIVE INGREDIENT2G86QN327LDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WODOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WODOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53489-120DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]23Current NDC, Legacy NDC, 4 package rows20250427_214a9cfe-a522-4022-81d4-e59f447401fe.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.c8194d6e-c407-465e-a342-4d2d9756dfc42026-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062677
application number: ANDA062677
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.cf95b2ca-2cf8-49a8-8e3a-f9b0f5b2072c2026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062677
application number: ANDA062677
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.3af9348c-a98b-4059-a5ef-4229e2b33af02026-07-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062677
application number: ANDA062677
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.1401d590-0967-4c6b-b52b-a83e9f6df0972026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062677
application number: ANDA062677
Doxycycline HyclateDOXYCYCLINE HYCLATESun Pharmaceutical Industries, Inc.214a9cfe-a522-4022-81d4-e59f447401fe2026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062677
application number: ANDA062677
ndc (product): 53489-120
Doxycycline HyclateDOXYCYCLINE HYCLATEAvPAK53ff9f7e-0db0-c841-d334-4cf31f6588282025-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062677
application number: ANDA062677

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN1401d590-0967-4c6b-b52b-a83e9f6df09743
1650143doxycycline hyclate 100 MG Oral TabletSCD1401d590-0967-4c6b-b52b-a83e9f6df09743
1650143doxycycline hyclate 100 MG Oral TabletPSN3af9348c-a98b-4059-a5ef-4229e2b33af030
1650143doxycycline hyclate 100 MG Oral TabletSCD3af9348c-a98b-4059-a5ef-4229e2b33af030
1650143doxycycline hyclate 100 MG Oral TabletPSNcf95b2ca-2cf8-49a8-8e3a-f9b0f5b2072c24
1650143doxycycline hyclate 100 MG Oral TabletSCDcf95b2ca-2cf8-49a8-8e3a-f9b0f5b2072c24
1650143doxycycline hyclate 100 MG Oral TabletPSNc8194d6e-c407-465e-a342-4d2d9756dfc416
1650143doxycycline hyclate 100 MG Oral TabletSCDc8194d6e-c407-465e-a342-4d2d9756dfc416
1649988doxycycline hyclate 100 MG Oral CapsulePSN53ff9f7e-0db0-c841-d334-4cf31f6588288
1650143doxycycline hyclate 100 MG Oral TabletPSN53ff9f7e-0db0-c841-d334-4cf31f6588288
1649405doxycycline hyclate 50 MG Oral CapsulePSN53ff9f7e-0db0-c841-d334-4cf31f6588288
1649988doxycycline hyclate 100 MG Oral CapsuleSCD53ff9f7e-0db0-c841-d334-4cf31f6588288
1650143doxycycline hyclate 100 MG Oral TabletSCD53ff9f7e-0db0-c841-d334-4cf31f6588288
1649405doxycycline hyclate 50 MG Oral CapsuleSCD53ff9f7e-0db0-c841-d334-4cf31f6588288
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY53ff9f7e-0db0-c841-d334-4cf31f6588288
1650143doxycycline hyclate 100 MG Oral TabletPSN465c5c54-d9b2-4ad5-a3f3-dbee6acfb9853
1650143doxycycline hyclate 100 MG Oral TabletSCD465c5c54-d9b2-4ad5-a3f3-dbee6acfb9853
1650143doxycycline hyclate 100 MG Oral TabletPSNbdaeb1eb-2f7b-3072-e053-2995a90acbd82
1650143doxycycline hyclate 100 MG Oral TabletPSNccfe4e5e-b77c-42eb-9c77-f3bd2115d36c2
1650143doxycycline hyclate 100 MG Oral TabletSCDbdaeb1eb-2f7b-3072-e053-2995a90acbd82
1650143doxycycline hyclate 100 MG Oral TabletSCDccfe4e5e-b77c-42eb-9c77-f3bd2115d36c2
1650143doxycycline hyclate 100 MG Oral TabletPSN2b5a2794-49cd-6a30-e054-00144ff88e881
1650143doxycycline hyclate 100 MG Oral TabletSCD2b5a2794-49cd-6a30-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53489-120-0153489012001100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-120-01) 2023-12-05NoNoCurrent
53489-120-025348901200250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-120-02) 1986-07-100000-00-00NoNoCurrent
53489-120-0553489012005500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-120-05) 1986-07-100000-00-00NoNoCurrent
53489-120-605348901206020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-120-60) 1986-07-100000-00-00NoNoCurrent