DOXYCYCLINE HYCLATE

Product NDC
43547-324
11-digit product format
435470324
Labeler code
43547
Product ID
43547-324_49c9be01-a1bf-48aa-8ef4-0584e8dcaac5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE HYCLATE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Solco Healthcare US LLC
Application
ANDA207494
Marketing category
ANDA
Marketing start
2016-11-28
Substance
DOXYCYCLINE HYCLATE
Active strength
150 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A207494-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-15
A207494-002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 200MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-15
A207494-003DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 50MG BASETABLET, DELAYED RELEASE / ORALAB2019-02-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207494-001AB
A207494-002AB
A207494-003AB

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 3 · 119 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207494-001DOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207494-002DOXYCYCLINE HYCLATEEQ 200MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207494-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET, DELAYED RELEASE / ORALAB2019-02-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207494-001DOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207494-002DOXYCYCLINE HYCLATEEQ 200MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207494-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET, DELAYED RELEASE / ORALAB2019-02-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A207494-001DOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207494-002DOXYCYCLINE HYCLATEEQ 200MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207494-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET, DELAYED RELEASE / ORALAB2019-02-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207494-001DOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207494-002DOXYCYCLINE HYCLATEEQ 200MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207494-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET, DELAYED RELEASE / ORALAB2019-02-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207494-001DOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207494-002DOXYCYCLINE HYCLATEEQ 200MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207494-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET, DELAYED RELEASE / ORALAB2019-02-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207494-001DOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207494-002DOXYCYCLINE HYCLATEEQ 200MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207494-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET, DELAYED RELEASE / ORALAB2019-02-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207494-001DOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207494-002DOXYCYCLINE HYCLATEEQ 200MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207494-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET, DELAYED RELEASE / ORALAB2019-02-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207494-001DOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207494-002DOXYCYCLINE HYCLATEEQ 200MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207494-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET, DELAYED RELEASE / ORALAB2019-02-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207494-001DOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207494-002DOXYCYCLINE HYCLATEEQ 200MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207494-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET, DELAYED RELEASE / ORALAB2019-02-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207494-001DOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A207494-002DOXYCYCLINE HYCLATEEQ 200MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A207494-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET, DELAYED RELEASE / ORALAB2019-02-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207494-001DOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207494-002DOXYCYCLINE HYCLATEEQ 200MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207494-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET, DELAYED RELEASE / ORALAB2019-02-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207494-001DOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207494-002DOXYCYCLINE HYCLATEEQ 200MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207494-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET, DELAYED RELEASE / ORALAB2019-02-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207494-001DOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207494-002DOXYCYCLINE HYCLATEEQ 200MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207494-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET, DELAYED RELEASE / ORALAB2019-02-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207494-001DOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2016-11-158072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 119 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207494-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207494-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207494-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207494-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207494-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207494-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207494-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207494-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207494-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207494-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207494-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207494-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207494-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207494-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207494-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207494-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207494-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207494-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207494-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207494-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207494-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207494-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207494-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207494-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207494-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207494-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207494-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207494-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207494-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207494-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207494-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207494-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207494-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207494-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207494-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207494-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207494-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207494-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207494-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207494-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
DOXYCYCLINE HYCLATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
19XTS3T51UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
799048Internal RxNorm lookup
1423080Internal RxNorm lookup
1653433Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0a18d4c7-9484-4d3e-b61b-e81fe63fefecAvailable 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d2d36660-68ce-7e7d-0630-ec4b0d859fadProduct name620220921
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
a239f4dd-cf93-4660-b190-f97d000f249fProduct name720210607
a9d03566-caeb-4466-8021-74599b048880Product name320210604
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
12750814-20f7-4f35-b5fa-dbc8811ba858Product name920201007
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
00a5dbaa-1b7d-4e56-be0c-fedc7bbf5adeProduct name120200706
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7b4b06ac-8c50-45f0-9556-293ea558a294Product name120180808
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84Product name520171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371Product name220171115
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
58b1278c-6dce-49b6-a05e-ea16f389acbaProduct name120160620
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-324-06DOXYCYCLINE HYCLATE60 in 1 BOTTLETABLET, DELAYED RELEASE607
43547-324-10DOXYCYCLINE HYCLATE100 in 1 BOTTLETABLET, DELAYED RELEASE1007
43547-324-50DOXYCYCLINE HYCLATE500 in 1 BOTTLETABLET, DELAYED RELEASE5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-324-10EA - Each43547-3245513c283-fcf1-4b5b-8e08-72708b20c1c012017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-324DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [SOLCO HEALTHCARE US LLC]4Current NDC, Legacy NDC, 3 package rows20210618_0a18d4c7-9484-4d3e-b61b-e81fe63fefec.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATESolco Healthcare US LLC0a18d4c7-9484-4d3e-b61b-e81fe63fefec2025-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207494
application number: ANDA207494
ndc (product): 43547-324
Doxycycline HyclateDOXYCYCLINE HYCLATESonoma Pharmaceuticals, Inc.4fa26176-a730-48ed-9659-e2f64212f4182018-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207494
application number: ANDA207494

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
799048doxycycline hyclate 150 MG Delayed Release Oral TabletPSN0a18d4c7-9484-4d3e-b61b-e81fe63fefec7
1423080doxycycline hyclate 200 MG Delayed Release Oral TabletPSN0a18d4c7-9484-4d3e-b61b-e81fe63fefec7
1653433doxycycline hyclate 50 MG Delayed Release Oral TabletPSN0a18d4c7-9484-4d3e-b61b-e81fe63fefec7
799048doxycycline hyclate 150 MG Delayed Release Oral TabletSCD0a18d4c7-9484-4d3e-b61b-e81fe63fefec7
1423080doxycycline hyclate 200 MG Delayed Release Oral TabletSCD0a18d4c7-9484-4d3e-b61b-e81fe63fefec7
1653433doxycycline hyclate 50 MG Delayed Release Oral TabletSCD0a18d4c7-9484-4d3e-b61b-e81fe63fefec7
799048doxycycline hyclate 150 MG Delayed Release Oral TabletPSN4fa26176-a730-48ed-9659-e2f64212f4183
799048doxycycline hyclate 150 MG Delayed Release Oral TabletSCD4fa26176-a730-48ed-9659-e2f64212f4183

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-324-064354703240660 TABLET, DELAYED RELEASE in 1 BOTTLE (43547-324-06) 2016-11-280000-00-00NoNoCurrent
43547-324-1043547032410100 TABLET, DELAYED RELEASE in 1 BOTTLE (43547-324-10) 2016-11-280000-00-00NoNoCurrent
43547-324-5043547032450500 TABLET, DELAYED RELEASE in 1 BOTTLE (43547-324-50) 2016-11-280000-00-00NoNoCurrent