Doxycycline Hyclate

Product NDC
62332-481
11-digit product format
623320481
Labeler code
62332
Product ID
62332-481_79225960-dfaf-43a0-8698-9c83ee345ea6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA213075
Marketing category
ANDA
Marketing start
2022-01-04
Substance
DOXYCYCLINE HYCLATE
Active strength
75 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213075-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 75MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-03
A213075-002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-03
A213075-003DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-03
A213075-004DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 200MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A213075-001AB
A213075-002AB
A213075-003AB
A213075-004AB

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 · 128 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213075-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213075-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213075-003DOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213075-004DOXYCYCLINE HYCLATEEQ 200MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213075-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213075-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213075-003DOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213075-004DOXYCYCLINE HYCLATEEQ 200MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A213075-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213075-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213075-003DOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213075-004DOXYCYCLINE HYCLATEEQ 200MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213075-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213075-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213075-003DOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213075-004DOXYCYCLINE HYCLATEEQ 200MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213075-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213075-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213075-003DOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213075-004DOXYCYCLINE HYCLATEEQ 200MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213075-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213075-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213075-003DOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213075-004DOXYCYCLINE HYCLATEEQ 200MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213075-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213075-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213075-003DOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213075-004DOXYCYCLINE HYCLATEEQ 200MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213075-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213075-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213075-003DOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213075-004DOXYCYCLINE HYCLATEEQ 200MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213075-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213075-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213075-003DOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213075-004DOXYCYCLINE HYCLATEEQ 200MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213075-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A213075-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A213075-003DOXYCYCLINE HYCLATEEQ 150MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A213075-004DOXYCYCLINE HYCLATEEQ 200MG BASETABLET, DELAYED RELEASE / ORALAB2022-01-03d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 128 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213075-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213075-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213075-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213075-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213075-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213075-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213075-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213075-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213075-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213075-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213075-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213075-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213075-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213075-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213075-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213075-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213075-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213075-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213075-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213075-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213075-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213075-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213075-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213075-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213075-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213075-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213075-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213075-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213075-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213075-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213075-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213075-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213075-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213075-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213075-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213075-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213075-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213075-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213075-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213075-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Doxycycline Hyclate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE75 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
406524Internal RxNorm lookup
434018Internal RxNorm lookup
799048Internal RxNorm lookup
1423080Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ae4ca12-be39-46b9-bc4c-f8356776c175Available 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
62332-481-31Doxycycline Hyclate100 in 1 BOTTLETABLET, DELAYED RELEASE1009
62332-481-60Doxycycline Hyclate60 in 1 BOTTLETABLET, DELAYED RELEASE609
62332-481-91Doxycycline Hyclate1000 in 1 BOTTLETABLET, DELAYED RELEASE10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-481-31EA - Each62332-4815b38bea2-486d-4b1e-aa3f-f14a5786de0c12022-09-12
62332-481-60EA - Each62332-48105d407b9-547a-460a-a67e-512b399c6cab12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-481DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 3 package rows20230411_3ae4ca12-be39-46b9-bc4c-f8356776c175.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 HYCLATEAlembic Pharmaceuticals Inc.3ae4ca12-be39-46b9-bc4c-f8356776c1752026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213075
application number: ANDA213075
ndc (product): 62332-481
Doxycycline HyclateDOXYCYCLINE HYCLATEAlembic Pharmaceuticals Limited44ac5de1-c0c6-4d58-9a49-b2dae60ea9212023-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213075
application number: ANDA213075

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
434018doxycycline hyclate 100 MG Delayed Release Oral TabletPSN3ae4ca12-be39-46b9-bc4c-f8356776c1759
799048doxycycline hyclate 150 MG Delayed Release Oral TabletPSN3ae4ca12-be39-46b9-bc4c-f8356776c1759
1423080doxycycline hyclate 200 MG Delayed Release Oral TabletPSN3ae4ca12-be39-46b9-bc4c-f8356776c1759
406524doxycycline hyclate 75 MG Delayed Release Oral TabletPSN3ae4ca12-be39-46b9-bc4c-f8356776c1759
434018doxycycline hyclate 100 MG Delayed Release Oral TabletSCD3ae4ca12-be39-46b9-bc4c-f8356776c1759
799048doxycycline hyclate 150 MG Delayed Release Oral TabletSCD3ae4ca12-be39-46b9-bc4c-f8356776c1759
1423080doxycycline hyclate 200 MG Delayed Release Oral TabletSCD3ae4ca12-be39-46b9-bc4c-f8356776c1759
406524doxycycline hyclate 75 MG Delayed Release Oral TabletSCD3ae4ca12-be39-46b9-bc4c-f8356776c1759

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-481-3162332048131100 TABLET, DELAYED RELEASE in 1 BOTTLE (62332-481-31) 2022-01-040000-00-00NoNoCurrent
62332-481-606233204816060 TABLET, DELAYED RELEASE in 1 BOTTLE (62332-481-60) 2022-01-040000-00-00NoNoCurrent
62332-481-91623320481911000 TABLET, DELAYED RELEASE in 1 BOTTLE (62332-481-91) 2022-01-040000-00-00NoNoCurrent