FDA.reportPublic FDA data

Doxycycline

Product NDC
64380-180
11-digit product format
643800180
Labeler code
64380
Product ID
64380-180_15fb10d4-5718-4fb0-bd3e-d514f72c8cb1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA065055
Marketing category
ANDA
Marketing start
2022-08-01
Substance
DOXYCYCLINE
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065055-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01
A065055-002DOXYCYCLINEDOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01
A065055-003DOXYCYCLINEDOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15
A065055-004DOXYCYCLINEDOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A065055-001AB
A065055-002AB
A065055-003AB

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 22:54:322026-06A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01a50c72e98297…
2026-08-01 22:54:322026-06A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01a50c72e98297…
2026-08-01 22:54:322026-06A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15a50c72e98297…
2026-08-01 22:54:322026-06A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A065055-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A065055-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A065055-003AB1a50c72e98297…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINEBryant Ranch Prepack04de98f3-33a2-48ba-85b5-9fac867524b72026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEGolden State Medical Supply, Inc.e9997efa-9ad8-3870-e053-2a95a90a1ac32026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEStrides Pharma Science Limited9e710113-f25e-46fb-8327-7a8e649613a22026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
ndc (product): 64380-180
DoxycyclineDOXYCYCLINEAmerican Health Packaginge49f8ff9-af7a-47eb-929b-238cff381c032026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEAmerican Health Packaging3fbf4bb8-036e-41d3-9628-476fc05ddd312026-02-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEBryant Ranch Prepack6285181d-e34d-4def-abe6-2c41254ada752026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEStrides Pharma Science Limitedd27c58a1-5c99-4007-9bc6-ad9b6fb56db82025-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINENuCare Pharmaceuticals,Inc.fa1da527-7a0f-8ed6-e053-6394a90a1b622024-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEProficient Rx LPc707566b-dbc7-4dac-bad1-952f2f4d68452024-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEA-S Medication Solutions6aab6fee-791e-4141-b55f-685ec9d8712a2023-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE100 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
728207Internal RxNorm lookup
1649401Internal 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
9e710113-f25e-46fb-8327-7a8e649613a2Available 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
64380-180-01Doxycycline50 in 1 BOTTLECAPSULE506
64380-180-02Doxycycline250 in 1 BOTTLECAPSULE2506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-180-01EA - Each64380-18065daed49-8d60-4719-ae94-f4995e6f00be12022-08-04
64380-180-02EA - Each64380-18010c6cc5e-f5ba-44c2-a80d-88682093c4c712022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-180DOXYCYCLINE CAPSULE [STRIDES PHARMA SCIENCE LIMITED]6Current NDC, Legacy NDC, 2 package rows20250323_9e710113-f25e-46fb-8327-7a8e649613a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSN04de98f3-33a2-48ba-85b5-9fac867524b7101
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD04de98f3-33a2-48ba-85b5-9fac867524b7101
1649990doxycycline monohydrate 100 MG Oral CapsulePSN9e710113-f25e-46fb-8327-7a8e649613a26
728207doxycycline monohydrate 150 MG Oral CapsulePSN9e710113-f25e-46fb-8327-7a8e649613a26
1649401doxycycline monohydrate 50 MG Oral CapsulePSN9e710113-f25e-46fb-8327-7a8e649613a26
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD9e710113-f25e-46fb-8327-7a8e649613a26
728207doxycycline monohydrate 150 MG Oral CapsuleSCD9e710113-f25e-46fb-8327-7a8e649613a26
1649401doxycycline monohydrate 50 MG Oral CapsuleSCD9e710113-f25e-46fb-8327-7a8e649613a26
1649990doxycycline monohydrate 100 MG Oral CapsulePSN3fbf4bb8-036e-41d3-9628-476fc05ddd313
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD3fbf4bb8-036e-41d3-9628-476fc05ddd313
1649990doxycycline monohydrate 100 MG Oral CapsulePSN115ecf3b-1369-cc6b-e063-6294a90aa3852
1649990doxycycline monohydrate 100 MG Oral CapsulePSNfa1da527-7a0f-8ed6-e053-6394a90a1b622
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD115ecf3b-1369-cc6b-e063-6294a90aa3852
1649990doxycycline monohydrate 100 MG Oral CapsuleSCDfa1da527-7a0f-8ed6-e053-6394a90a1b622
1649990doxycycline monohydrate 100 MG Oral CapsulePSN6aab6fee-791e-4141-b55f-685ec9d8712a1
1649990doxycycline monohydrate 100 MG Oral CapsulePSN0ab12b8f-1c26-4a58-e063-6394a90a17491
1649990doxycycline monohydrate 100 MG Oral CapsulePSNc707566b-dbc7-4dac-bad1-952f2f4d68451
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD6aab6fee-791e-4141-b55f-685ec9d8712a1
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD0ab12b8f-1c26-4a58-e063-6394a90a17491
1649990doxycycline monohydrate 100 MG Oral CapsuleSCDc707566b-dbc7-4dac-bad1-952f2f4d68451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-180-016438001800150 CAPSULE in 1 BOTTLE (64380-180-01) 50 capsule2022-08-010000-00-00NoNoCurrent
64380-180-0264380018002250 CAPSULE in 1 BOTTLE (64380-180-02) 250 capsule2022-11-09NoNoCurrent