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 43.

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-2284e616aacf4f…
2026-09-14 22:38:342026-08A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-2284e616aacf4f…
2026-09-14 22:38:342026-08A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-1084e616aacf4f…
2026-08-18 06:07:402026-07A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-22caaa826d4ba7…
2026-08-18 06:07:402026-07A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-22caaa826d4ba7…
2026-08-18 06:07:402026-07A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-10caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A065053-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A065053-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A065053-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A065053-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065053-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065053-003AB1caaa826d4ba7…
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…

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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

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