Doxycycline

Product NDC
63304-614
11-digit product format
633040614
Labeler code
63304
Product ID
63304-614_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
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 · 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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-228072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065053-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065053-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065053-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065053-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065053-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065053-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065053-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065053-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065053-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065053-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065053-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065053-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065053-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065053-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065053-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065053-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065053-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065053-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065053-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065053-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065053-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065053-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065053-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065053-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065053-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065053-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065053-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065053-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065053-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065053-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065053-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065053-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065053-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065053-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065053-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065053-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065053-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065053-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065053-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065053-001AB18072bd15b7f6…

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): 63304-614
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
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 · 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
63304-614-01Doxycycline100 in 1 BOTTLECAPSULE10010
63304-614-05Doxycycline500 in 1 BOTTLECAPSULE50010
63304-614-13Doxycycline120 in 1 BOTTLECAPSULE12010
63304-614-20Doxycycline20 in 1 BOTTLECAPSULE2010

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
63304-614DOXYCYCLINE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]10Current NDC, Legacy NDC, 4 package rows20250426_829dbd3d-5c2b-47b8-96a5-423af78c93b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63304-614-0163304061401100 CAPSULE in 1 BOTTLE (63304-614-01) 100 capsule2000-12-260000-00-00NoNoCurrent
63304-614-0563304061405500 CAPSULE in 1 BOTTLE (63304-614-05) 500 capsule2000-12-260000-00-00NoNoCurrent
63304-614-1363304061413120 CAPSULE in 1 BOTTLE (63304-614-13) 120 capsule2000-12-260000-00-00NoNoCurrent
63304-614-206330406142020 CAPSULE in 1 BOTTLE (63304-614-20) 20 capsule2000-12-260000-00-00NoNoCurrent