DOXYCYCLINE

Product NDC
63187-672
11-digit product format
631870672
Labeler code
63187
Product ID
63187-672_7c29d1d4-f1a1-4fff-afc9-256163c09b87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204234
Marketing category
ANDA
Marketing start
2014-04-14
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
A204234-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-05
A204234-002DOXYCYCLINEDOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-05
A204234-003DOXYCYCLINEDOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204234-001AB
A204234-002AB
A204234-003AB

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 UTC2026-02A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-058072bd15b7f6…

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 UTC2026-02A204234-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204234-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204234-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204234-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204234-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204234-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204234-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204234-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204234-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204234-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204234-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204234-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204234-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204234-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204234-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204234-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204234-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204234-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204234-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204234-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204234-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204234-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204234-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204234-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204234-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204234-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204234-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204234-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204234-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204234-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204234-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204234-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204234-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204234-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204234-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204234-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204234-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204234-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204234-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204234-001AB18072bd15b7f6…

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
00ea3641-18da-4a6f-a779-e16075464d2bAvailable 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
63187-672-02DOXYCYCLINE2 in 1 BOTTLECAPSULE24
63187-672-06DOXYCYCLINE6 in 1 BOTTLECAPSULE64
63187-672-10DOXYCYCLINE10 in 1 BOTTLECAPSULE104
63187-672-14DOXYCYCLINE14 in 1 BOTTLECAPSULE144
63187-672-20DOXYCYCLINE20 in 1 BOTTLECAPSULE204
63187-672-30DOXYCYCLINE30 in 1 BOTTLECAPSULE304
63187-672-40DOXYCYCLINE40 in 1 BOTTLECAPSULE404

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-672-02EA - Each63187-6728a054e8c-c98a-47de-94b2-8dd7e40be46d12019-06-19
63187-672-06EA - Each63187-672d60ec058-04b8-4877-a08b-dd9d24e2c70812026-02-05
63187-672-20EA - Each63187-67225b63724-68d4-413e-b24d-66392d1cff9b12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-672DOXYCYCLINE CAPSULE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 7 package rows20200218_00ea3641-18da-4a6f-a779-e16075464d2b.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOXYCYCLINEDOXYCYCLINEREMEDYREPACK INC.fa2d9328-b688-47af-8c4d-dc328cf353922026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204234
application number: ANDA204234
DOXYCYCLINEDOXYCYCLINENorthwind Health Company, LLCf3319f4f-b535-da12-e053-2995a90ac00f2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204234
application number: ANDA204234
DOXYCYCLINEDOXYCYCLINEProficient Rx LP00ea3641-18da-4a6f-a779-e16075464d2b2025-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204234
application number: ANDA204234
ndc (product): 63187-672
DOXYCYCLINEDOXYCYCLINELupin Pharmaceuticals, Inc.bcc65910-30d8-4807-ab61-607a563829242024-11-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204234
application number: ANDA204234

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSN00ea3641-18da-4a6f-a779-e16075464d2b4
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD00ea3641-18da-4a6f-a779-e16075464d2b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-672-02631870672022 CAPSULE in 1 BOTTLE (63187-672-02) 2 capsule2019-03-010000-00-00NoNoCurrent
63187-672-06631870672066 CAPSULE in 1 BOTTLE (63187-672-06) 6 capsule2025-09-16NoNoCurrent
63187-672-106318706721010 CAPSULE in 1 BOTTLE (63187-672-10) 10 capsule2016-04-010000-00-00NoNoCurrent
63187-672-146318706721414 CAPSULE in 1 BOTTLE (63187-672-14) 14 capsule2016-04-010000-00-00NoNoCurrent
63187-672-206318706722020 CAPSULE in 1 BOTTLE (63187-672-20) 20 capsule2016-04-010000-00-00NoNoCurrent
63187-672-306318706723030 CAPSULE in 1 BOTTLE (63187-672-30) 30 capsule2016-04-010000-00-00NoNoCurrent
63187-672-406318706724040 CAPSULE in 1 BOTTLE (63187-672-40) 40 capsule2016-04-010000-00-00NoNoCurrent