FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
0904-0428
11-digit product format
009040428
Labeler code
0904
Product ID
0904-0428_3b8646ca-1254-4467-8ae0-9ea01a2dde6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA062396
Marketing category
ANDA
Marketing start
2008-08-05
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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABRS1984-05-07a50c72e98297…
2026-08-01 22:54:322026-06A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A062396-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A062396-002AB1a50c72e98297…

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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
ndc (product): 0904-0428
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

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
c4aae81f-0219-450f-aa60-953964f74172Available 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
0904-0428-04Doxycycline Hyclate30 in 1 CARTONCAPSULE3017
0904-0428-04Doxycycline Hyclate1 in 1 BLISTER PACKCAPSULE117
0904-0428-06Doxycycline Hyclate1 in 1 BLISTER PACKCAPSULE117
0904-0428-06Doxycycline Hyclate50 in 1 CARTONCAPSULE5017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-0428-04EA - Each0904-04286c7f92e3-d467-4c90-a6be-7ff318483e8412019-09-05
0904-0428-06EA - Each0904-0428e0fcfd55-5f82-4111-9d83-b6af581713b012019-09-05
0904-0428-40EA - Each0904-0428a2a8d5a4-d144-40ed-8ca7-a06b7544026d12013-02-11
0904-0428-51EA - Each0904-04280cd4b802-92cc-4137-aa9e-99abc38cb23112013-02-11
0904-0428-61EA - Each0904-0428d75cca9d-d64d-4a75-98d7-08564bb7e4ce12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE CAPSULE [BLENHEIM PHARMACAL, INC.]2
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE CAPSULE [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE CAPSULE [BLENHEIM PHARMACAL, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE CAPSULE [BLENHEIM PHARMACAL, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXYCYCLINE HYCLATE CAPSULE [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE CAPSULE [BLENHEIM PHARMACAL, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE HYCLATE CAPSULE [BLENHEIM PHARMACAL, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXYCYCLINE HYCLATE CAPSULE [BLENHEIM PHARMACAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE CAPSULE [BLENHEIM PHARMACAL, INC.]2
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-0428DOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]15Current NDC, Legacy NDC, 4 package rows20250226_c4aae81f-0219-450f-aa60-953964f74172.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSNc4aae81f-0219-450f-aa60-953964f7417217
1649988doxycycline hyclate 100 MG Oral CapsuleSCDc4aae81f-0219-450f-aa60-953964f7417217
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYc4aae81f-0219-450f-aa60-953964f7417217
1649988doxycycline hyclate 100 MG Oral CapsulePSN3340cc23-b17c-4d4f-bfc4-99d6ca182f8a2
1649988doxycycline hyclate 100 MG Oral CapsuleSCD3340cc23-b17c-4d4f-bfc4-99d6ca182f8a2
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY3340cc23-b17c-4d4f-bfc4-99d6ca182f8a2
1649988doxycycline hyclate 100 MG Oral CapsulePSN623cd471-778e-4843-baab-e7a072d0021b1
1649988doxycycline hyclate 100 MG Oral CapsulePSN8d8ea1c1-0c89-4a10-85bb-de2c96ca34f01
1649988doxycycline hyclate 100 MG Oral CapsuleSCD623cd471-778e-4843-baab-e7a072d0021b1
1649988doxycycline hyclate 100 MG Oral CapsuleSCD8d8ea1c1-0c89-4a10-85bb-de2c96ca34f01
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY623cd471-778e-4843-baab-e7a072d0021b1
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY8d8ea1c1-0c89-4a10-85bb-de2c96ca34f01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-0428-040090404280430 BLISTER PACK in 1 CARTON (0904-0428-04) / 1 CAPSULE in 1 BLISTER PACK30 blister pack2008-08-050000-00-00NoNoCurrent
0904-0428-060090404280650 BLISTER PACK in 1 CARTON (0904-0428-06) / 1 CAPSULE in 1 BLISTER PACK50 blister pack2008-08-050000-00-00NoNoCurrent