Doxycycline

Product NDC
49884-305
11-digit product format
498840305
Labeler code
49884
Product ID
49884-305_da765403-ebf9-4189-894d-61678ab69965
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA065055
Marketing category
ANDA
Marketing start
2011-06-01
Marketing end
2024-02-28
Substance
DOXYCYCLINE
Active strength
150 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49884-305DDiscontinued by firm2026-08-03
excluded packagepackage49884-30549884-305-02DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49884-305-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49884-305-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49884-305-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49884-305-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49884-305-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49884-305-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49884-305-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49884-305-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49884-305-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49884-305-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49884-305-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49884-305-02557ba5c1ecfa…9c80585c8c6e…

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.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18d06236e962d9…

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 UTC2026-02A065055-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065055-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065055-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065055-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065055-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065055-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065055-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065055-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065055-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065055-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065055-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065055-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065055-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065055-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065055-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065055-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065055-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065055-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065055-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065055-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065055-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065055-001AB18072bd15b7f6…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49884-305-022022-08-25C16284748780-1e4f33bdf-a902-d8a0-e053-dadaa90a6e4eDoxycycline Capsules USP
49884-305-022022-07-29C16284748780-1e4f33bdf-a902-d8a0-e053-dadaa90a6e4eDoxycycline Capsules USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-305-02EA - Each49884-305eab83063-fde8-42e4-a69e-214f09acc33912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINEACTIVE INGREDIENTN12000U13ODOXYCYCLINE CAPSULE [PAR PHARMACEUTICAL INC.]10
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE CAPSULE [PAR PHARMACEUTICAL INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE CAPSULE [PAR PHARMACEUTICAL INC.]10
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLINE CAPSULE [PAR PHARMACEUTICAL INC.]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOXYCYCLINE CAPSULE [PAR PHARMACEUTICAL INC.]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXYCYCLINE CAPSULE [PAR PHARMACEUTICAL INC.]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DOXYCYCLINE CAPSULE [PAR PHARMACEUTICAL INC.]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDOXYCYCLINE CAPSULE [PAR PHARMACEUTICAL INC.]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DOXYCYCLINE CAPSULE [PAR PHARMACEUTICAL INC.]10
GELATININACTIVE INGREDIENT2G86QN327LDOXYCYCLINE CAPSULE [PAR PHARMACEUTICAL INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE CAPSULE [PAR PHARMACEUTICAL INC.]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE CAPSULE [PAR PHARMACEUTICAL INC.]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DOXYCYCLINE CAPSULE [PAR PHARMACEUTICAL INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE CAPSULE [PAR PHARMACEUTICAL INC.]10

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 · 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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-305-024988403050260 CAPSULE in 1 BOTTLE (49884-305-02) 60 capsule2011-06-010000-00-00NoNoCurrent