FDA.reportPublic FDA data

Doxycycline

Product NDC
63304-616
11-digit product format
633040616
Labeler code
63304
Product ID
63304-616_338488d1-e9d8-6b00-e063-6294a90a37c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA065053
Marketing category
ANDA
Marketing start
2000-12-26
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065053-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-22
A065053-002DOXYCYCLINEDOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-22
A065053-003DOXYCYCLINEDOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065053-001AB
A065053-002AB
A065053-003AB

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 22:54:322026-06A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-22a50c72e98297…
2026-08-01 22:54:322026-06A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-22a50c72e98297…
2026-08-01 22:54:322026-06A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A065053-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A065053-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A065053-003AB1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINESun Pharmaceutical Industries, Inc.829dbd3d-5c2b-47b8-96a5-423af78c93b92025-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065053
application number: ANDA065053
ndc (product): 63304-616
Doxycycline MonohydrateDOXYCYCLINE MONOHYDRATEDirect_Rxdfef600c-bceb-fbc9-e053-2a95a90ae6c02025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065053
application number: ANDA065053
DoxycyclineDOXYCYCLINEBryant Ranch Prepack4b170180-21f4-4ee5-9e81-1607ab52cfca2024-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065053
application number: ANDA065053

Additional Listing Data#

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

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
700408Internal 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
829dbd3d-5c2b-47b8-96a5-423af78c93b9Available 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
63304-616-01Doxycycline100 in 1 BOTTLECAPSULE10010
63304-616-05Doxycycline500 in 1 BOTTLECAPSULE50010
63304-616-13Doxycycline120 in 1 BOTTLECAPSULE12010
63304-616-20Doxycycline20 in 1 BOTTLECAPSULE2010
63304-616-50Doxycycline50 in 1 BOTTLECAPSULE5010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-616-50EA - Each63304-61666fe5663-0ab0-4611-8a5b-8a44932fe1cb12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINEACTIVE INGREDIENTN12000U13ODOXYCYCLINE CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDOXYCYCLINE CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DOXYCYCLINE CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
GELATININACTIVE INGREDIENT2G86QN327LDOXYCYCLINE CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TDOXYCYCLINE CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOXYCYCLINE CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
SHELLACINACTIVE INGREDIENT46N107B71ODOXYCYCLINE CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DOXYCYCLINE CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE CAPSULE [RANBAXY PHARMACEUTICALS INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-616DOXYCYCLINE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]10Current NDC, Legacy NDC, 5 package rows20250426_829dbd3d-5c2b-47b8-96a5-423af78c93b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSN4b170180-21f4-4ee5-9e81-1607ab52cfca102
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD4b170180-21f4-4ee5-9e81-1607ab52cfca102
1649990doxycycline monohydrate 100 MG Oral CapsulePSN829dbd3d-5c2b-47b8-96a5-423af78c93b910
1649401doxycycline monohydrate 50 MG Oral CapsulePSN829dbd3d-5c2b-47b8-96a5-423af78c93b910
700408doxycycline monohydrate 75 MG Oral CapsulePSN829dbd3d-5c2b-47b8-96a5-423af78c93b910
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD829dbd3d-5c2b-47b8-96a5-423af78c93b910
1649401doxycycline monohydrate 50 MG Oral CapsuleSCD829dbd3d-5c2b-47b8-96a5-423af78c93b910
700408doxycycline monohydrate 75 MG Oral CapsuleSCD829dbd3d-5c2b-47b8-96a5-423af78c93b910
1649990doxycycline monohydrate 100 MG Oral CapsulePSNa37e73ab-0983-7a24-e053-2a95a90acdea4
1649990doxycycline monohydrate 100 MG Oral CapsuleSCDa37e73ab-0983-7a24-e053-2a95a90acdea4
1649990doxycycline monohydrate 100 MG Oral CapsulePSNdfef600c-bceb-fbc9-e053-2a95a90ae6c02
1649990doxycycline monohydrate 100 MG Oral CapsuleSCDdfef600c-bceb-fbc9-e053-2a95a90ae6c02
1649990doxycycline monohydrate 100 MG Oral CapsulePSNe7a69d4c-8a7f-4641-821d-acf5d7be3d521
1649990doxycycline monohydrate 100 MG Oral CapsuleSCDe7a69d4c-8a7f-4641-821d-acf5d7be3d521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63304-616-0163304061601100 CAPSULE in 1 BOTTLE (63304-616-01) 100 capsule2000-12-260000-00-00NoNoCurrent
63304-616-0563304061605500 CAPSULE in 1 BOTTLE (63304-616-05) 500 capsule2000-12-260000-00-00NoNoCurrent
63304-616-1363304061613120 CAPSULE in 1 BOTTLE (63304-616-13) 120 capsule2000-12-260000-00-00NoNoCurrent
63304-616-206330406162020 CAPSULE in 1 BOTTLE (63304-616-20) 20 capsule2000-12-260000-00-00NoNoCurrent
63304-616-506330406165050 CAPSULE in 1 BOTTLE (63304-616-50) 50 capsule2000-12-260000-00-00NoNoCurrent