Doxycycline Hyclate

Product NDC
68071-4950
Requested package NDC
68071-4950-4
11-digit product format
680714950
Labeler code
68071
Product ID
68071-4950_43e7457d-17b3-32f7-e063-6294a90afee4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA062396
Marketing category
ANDA
Marketing start
1990-09-01
Substance
DOXYCYCLINE HYCLATE
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062396-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABRS1984-05-07
A062396-002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A062396-001AB
A062396-002AB

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABRS1984-05-0784e616aacf4f…
2026-09-14 22:38:342026-08A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-0784e616aacf4f…
2026-08-18 06:07:402026-07A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABRS1984-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABRS1984-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABRS1984-05-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABRS1984-05-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABRS1984-05-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-0774a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A062396-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A062396-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A062396-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A062396-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062396-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062396-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062396-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062396-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062396-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062396-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062396-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062396-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062396-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062396-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062396-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062396-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062396-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062396-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062396-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062396-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062396-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062396-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062396-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A062396-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062396-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062396-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062396-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062396-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062396-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062396-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062396-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062396-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062396-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062396-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062396-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062396-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062396-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062396-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062396-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062396-002AB174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Doxycycline Hyclate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE100 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1649988Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8c525e4e-6e1b-4579-e053-2a95a90a43daAvailable 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
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84Product name520171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371Product name220171115
58b1278c-6dce-49b6-a05e-ea16f389acbaProduct name120160620
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4950-42021-02-18C16284748780-1ba0f9c33-1308-a910-e053-dadaa90a0b85Doxycycline Hyclate Capsules - Hikma
68071-4950-42021-01-29C16284748780-1ba0f9c33-1308-a910-e053-dadaa90a0b85Doxycycline Hyclate Capsules - Hikma

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4950-2Doxycycline Hyclate20 in 1 BOTTLECAPSULE206
68071-4950-3Doxycycline Hyclate30 in 1 BOTTLECAPSULE306
68071-4950-4Doxycycline Hyclate14 in 1 BOTTLECAPSULE146
68071-4950-8Doxycycline Hyclate28 in 1 BOTTLECAPSULE286

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4950DOXYCYCLINE HYCLATE CAPSULE [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 4 package rows20240619_8c525e4e-6e1b-4579-e053-2a95a90a43da.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxycycline HyclateDOXYCYCLINE HYCLATEA-S Medication Solutions9ecadbc8-3087-4692-916a-b7f392d8e8da2026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycyclate HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.4dc319c1-b7ef-40e4-9e66-fb24cfdefea82026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEUnit Dose Solutions, Inc.548d4218-2feb-8716-e063-6394a90afbe32026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.e24a3292-0d4f-4692-8cf7-a82bd19e59322026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.5f523294-e62b-4da5-8799-047d4bed966f2026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATECoupler LLC52ba329a-8cb3-cf30-e063-6394a90aa0dc2026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.3a85933f-bd73-4ad7-968d-c90cb7c7a60c2026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATENorthwind Health Company, LLCf309ccbb-b68a-3190-e053-2995a90a0ad42026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEMajor Pharmaceuticalsc4aae81f-0219-450f-aa60-953964f741722025-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATENuCare Pharmaceuticals,Inc.8c525e4e-6e1b-4579-e053-2a95a90a43da2025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
ndc (package): 68071-4950-4
ndc (product): 68071-4950
ndc11 (package): 68071495004
Doxycycline HyclateDOXYCYCLINE HYCLATEAmerican Health Packaginge98d11b0-535f-4e57-9639-6358835c04bc2025-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEHikma Pharmaceuticals USA Inc.4ec4c8ca-ce83-4948-8626-21eb82ae5c192025-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATECoupler LLC325d5331-d48e-1bc4-e063-6394a90a65b92025-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
DoxycyclineDOXYCYCLINEDirect_Rx8c273efa-62ec-16b2-e053-2995a90ac41d2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEBryant Ranch Prepack214e5a5c-7f3e-478b-93d3-1713de9e76722024-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATENuCare Pharmaceuticals,Inc.88012cf8-509b-84cf-e053-2a95a90af3bc2024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN8c525e4e-6e1b-4579-e053-2a95a90a43da6
1649988doxycycline hyclate 100 MG Oral CapsuleSCD8c525e4e-6e1b-4579-e053-2a95a90a43da6
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY8c525e4e-6e1b-4579-e053-2a95a90a43da6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4950-46807149500414 CAPSULE in 1 BOTTLE (68071-4950-4) 14 capsule2019-06-270000-00-00NoNoCurrent