FDA.reportPublic FDA data

Doxycycline

Product NDC
46708-249
11-digit product format
467080249
Labeler code
46708
Product ID
46708-249_7bd9362d-42fd-4f01-bed9-3797d0c1d6ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA209165
Marketing category
ANDA
Marketing start
2017-07-31
Substance
DOXYCYCLINE
Active strength
75 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
A209165-001DOXYCYCLINEDOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2017-07-28
A209165-002DOXYCYCLINEDOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2017-07-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209165-001AB
A209165-002AB

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 22:54:322026-06A209165-001DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2017-07-28a50c72e98297…
2026-08-01 22:54:322026-06A209165-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2017-07-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209165-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A209165-002AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINEProficient Rx LPd9388b32-dcb8-4dff-8a35-8fccb31bd1f82026-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209165
application number: ANDA209165
DoxycyclineDOXYCYCLINEAlembic Pharmaceuticals Inc.d77e2a9c-c536-4e66-b87a-40b0857376992025-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209165
application number: ANDA209165
DoxycyclineDOXYCYCLINENuCare Pharmaceuticals,Inc.2a07049d-3950-d293-e063-6294a90a44502024-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209165
application number: ANDA209165
DoxycyclineDOXYCYCLINEAlembic Pharmaceuticals Limited3dfa486c-4665-4882-93ac-9259708f899c2023-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209165
application number: ANDA209165
ndc (product): 46708-249

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N12000U13OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
700408Internal RxNorm lookup
1649990Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3dfa486c-4665-4882-93ac-9259708f899cAvailable 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
46708-249-30Doxycycline30 in 1 BOTTLECAPSULE304
46708-249-31Doxycycline100 in 1 BOTTLECAPSULE1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-249DOXYCYCLINE CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED]4Current NDC, Legacy NDC, 2 package rows20230129_3dfa486c-4665-4882-93ac-9259708f899c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSN3dfa486c-4665-4882-93ac-9259708f899c4
700408doxycycline monohydrate 75 MG Oral CapsulePSN3dfa486c-4665-4882-93ac-9259708f899c4
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD3dfa486c-4665-4882-93ac-9259708f899c4
700408doxycycline monohydrate 75 MG Oral CapsuleSCD3dfa486c-4665-4882-93ac-9259708f899c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-249-304670802493030 CAPSULE in 1 BOTTLE (46708-249-30) 30 capsule2017-07-310000-00-00NoNoCurrent
46708-249-3146708024931100 CAPSULE in 1 BOTTLE (46708-249-31) 100 capsule2017-07-310000-00-00NoNoCurrent