FDA.reportPublic FDA data

Doxycycline

Product NDC
64380-205
11-digit product format
643800205
Labeler code
64380
Product ID
64380-205_38deaa0a-0200-49e4-9251-a86dbe2119d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA065070
Marketing category
ANDA
Marketing start
2022-09-19
Substance
DOXYCYCLINE
Active strength
50 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065070-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASETABLET / ORALAB2000-12-15
A065070-002DOXYCYCLINEDOXYCYCLINEEQ 100MG BASETABLET / ORALAB2000-12-15
A065070-003DOXYCYCLINEDOXYCYCLINEEQ 75MG BASETABLET / ORALAB2002-12-30
A065070-004DOXYCYCLINEDOXYCYCLINEEQ 150MG BASETABLET / ORALAB2005-07-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A065070-001AB
A065070-002AB
A065070-003AB
A065070-004AB

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 22:54:322026-06A065070-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2000-12-15a50c72e98297…
2026-08-01 22:54:322026-06A065070-002DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2000-12-15a50c72e98297…
2026-08-01 22:54:322026-06A065070-003DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2002-12-30a50c72e98297…
2026-08-01 22:54:322026-06A065070-004DOXYCYCLINEEQ 150MG BASETABLET / ORALAB2005-07-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A065070-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A065070-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A065070-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A065070-004AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINEStrides Pharma Science Limited3b9888a2-ca16-43f7-ab6d-f03188ec2c0d2025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065070
application number: ANDA065070
ndc (product): 64380-205

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE50 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1649429Internal RxNorm lookup
1650142Internal RxNorm lookup
1650444Internal RxNorm lookup
1652673Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3b9888a2-ca16-43f7-ab6d-f03188ec2c0dAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64380-205-012024-04-24C16284748780-11030e365-2864-111a-e063-dadaa90a10e2Doxycycline Tablets, USP Rx only
64380-205-012024-04-24C16284748780-11030e365-2864-111a-e063-dadaa90a10e2Doxycycline Tablets, USP Rx only
64380-205-012024-01-30C16284748780-11030e365-2864-111a-e063-dadaa90a10e2Doxycycline Tablets, USP Rx only
64380-205-012024-01-30C16284748780-11030e365-2864-111a-e063-dadaa90a10e2Doxycycline Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-205-01Doxycycline100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-205-01EA - Each64380-20522190e1a-f59e-4bab-bb2b-bc55615a3c1412022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-205DOXYCYCLINE TABLET [STRIDES PHARMA SCIENCE LIMITED]6Current NDC, Legacy NDC, 1 package rows20250323_3b9888a2-ca16-43f7-ab6d-f03188ec2c0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650142doxycycline monohydrate 100 MG Oral TabletPSN3b9888a2-ca16-43f7-ab6d-f03188ec2c0d6
1650444doxycycline monohydrate 150 MG Oral TabletPSN3b9888a2-ca16-43f7-ab6d-f03188ec2c0d6
1652673doxycycline monohydrate 50 MG Oral TabletPSN3b9888a2-ca16-43f7-ab6d-f03188ec2c0d6
1649429doxycycline monohydrate 75 MG Oral TabletPSN3b9888a2-ca16-43f7-ab6d-f03188ec2c0d6
1650142doxycycline monohydrate 100 MG Oral TabletSCD3b9888a2-ca16-43f7-ab6d-f03188ec2c0d6
1650444doxycycline monohydrate 150 MG Oral TabletSCD3b9888a2-ca16-43f7-ab6d-f03188ec2c0d6
1652673doxycycline monohydrate 50 MG Oral TabletSCD3b9888a2-ca16-43f7-ab6d-f03188ec2c0d6
1649429doxycycline monohydrate 75 MG Oral TabletSCD3b9888a2-ca16-43f7-ab6d-f03188ec2c0d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-205-0164380020501100 TABLET in 1 BOTTLE (64380-205-01) 100 tablet2022-09-190000-00-00NoNoCurrent