FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
33342-386
11-digit product format
333420386
Labeler code
33342
Product ID
33342-386_c36798a1-b865-4e94-9905-5af024a9e250
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA211137
Marketing category
ANDA
Marketing start
2025-12-09
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211137-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2025-12-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211137-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211137-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2025-12-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211137-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2025-12-0931067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211137-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2025-12-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211137-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211137-001AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211137-001AB1a50c72e98297…

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 · 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
c36798a1-b865-4e94-9905-5af024a9e250Available 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
33342-386-08Doxycycline Hyclate50 in 1 BOTTLECAPSULE501
33342-386-12Doxycycline Hyclate10 in 1 BLISTER PACKCAPSULE101
33342-386-12Doxycycline Hyclate10 in 1 CARTONCAPSULE101
33342-386-15Doxycycline Hyclate500 in 1 BOTTLECAPSULE5001

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxycycline HyclateDOXYCYCLINE HYCLATEMacleods Pharmaceuticals Limitedc36798a1-b865-4e94-9905-5af024a9e2502025-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211137
application number: ANDA211137
ndc (product): 33342-386

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSNc36798a1-b865-4e94-9905-5af024a9e2501
1649988doxycycline hyclate 100 MG Oral CapsuleSCDc36798a1-b865-4e94-9905-5af024a9e2501
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYc36798a1-b865-4e94-9905-5af024a9e2501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-386-083334203860850 CAPSULE in 1 BOTTLE (33342-386-08) 50 capsule2025-12-09NoNoCurrent
33342-386-123334203861210 BLISTER PACK in 1 CARTON (33342-386-12) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2025-12-09NoNoCurrent
33342-386-1533342038615500 CAPSULE in 1 BOTTLE (33342-386-15) 500 capsule2025-12-09NoNoCurrent