doxycycline

Product NDC
68382-706
11-digit product format
683820706
Labeler code
68382
Product ID
68382-706_9486a93f-bc2a-444a-a8d4-3bce410d21c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA205115
Marketing category
ANDA
Marketing start
2016-03-14
Substance
DOXYCYCLINE
Active strength
75 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
A205115-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-18
A205115-002DOXYCYCLINEDOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-18
A205115-003DOXYCYCLINEDOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205115-001AB
A205115-002AB
A205115-003AB

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 UTC2026-02A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-188072bd15b7f6…

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 UTC2026-02A205115-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205115-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205115-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205115-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205115-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205115-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205115-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205115-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205115-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205115-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205115-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205115-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205115-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205115-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205115-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205115-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205115-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205115-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205115-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205115-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205115-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205115-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205115-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205115-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205115-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205115-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205115-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205115-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205115-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205115-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205115-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205115-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205115-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205115-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205115-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205115-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205115-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205115-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205115-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205115-001AB18072bd15b7f6…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
doxycyclineDOXYCYCLINEPD-Rx Pharmaceuticals, Inc.7028b7f9-21cd-4c8e-97aa-a3e7d849939b2026-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
doxycyclineDOXYCYCLINEPD-Rx Pharmaceuticals, Inc.dedebcb4-3c3f-4487-a488-36af12640c922026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
DOXYCYCLINEDOXYCYCLINEDIRECT RX31512ece-cb16-2a9a-e054-00144ff88e882026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
doxycyclineDOXYCYCLINEA-S Medication Solutions2c7795c9-9e4e-477a-ad9f-01e4c55c06b62026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
doxycyclineDOXYCYCLINEAvPAKa5b28a41-db12-af7c-e053-2995a90ace092026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
doxycyclineDOXYCYCLINEZydus Pharmaceuticals USA Inc.fef9580d-8850-4cbb-89eb-2b4d40ee59c92025-04-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
ndc (product): 68382-706
doxycyclineDOXYCYCLINEZydus Lifesciences Limitedaa01035d-8b4a-4fdc-bfdf-2b39df0d8fc92024-11-28Exact identifier
application applno (ANDA): 205115
application number: ANDA205115
doxycyclineDOXYCYCLINEBryant Ranch Prepack5f989cc1-48ae-41bb-b297-2f8c83760b6d2024-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
doxycyclineDOXYCYCLINEProficient Rx LPf3ba6c30-ada3-4a57-9ff8-30558202b9aa2019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE75 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
700408Internal RxNorm lookup
1649401Internal RxNorm lookup
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
fef9580d-8850-4cbb-89eb-2b4d40ee59c9Available 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
68382-706-01doxycycline100 in 1 BOTTLECAPSULE1009
68382-706-05doxycycline500 in 1 BOTTLECAPSULE5009
68382-706-06doxycycline30 in 1 BOTTLECAPSULE309
68382-706-10doxycycline1000 in 1 BOTTLECAPSULE10009
68382-706-16doxycycline90 in 1 BOTTLECAPSULE909
68382-706-18doxycycline50 in 1 BOTTLECAPSULE509
68382-706-30doxycycline10 in 1 BLISTER PACKCAPSULE109
68382-706-77doxycycline10 in 1 CARTONCAPSULE109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-706DOXYCYCLINE CAPSULE [ZYDUS PHARMACEUTICALS USA INC.]9Current NDC, Legacy NDC, 8 package rows20250507_fef9580d-8850-4cbb-89eb-2b4d40ee59c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSNfef9580d-8850-4cbb-89eb-2b4d40ee59c99
1649401doxycycline monohydrate 50 MG Oral CapsulePSNfef9580d-8850-4cbb-89eb-2b4d40ee59c99
700408doxycycline monohydrate 75 MG Oral CapsulePSNfef9580d-8850-4cbb-89eb-2b4d40ee59c99
1649990doxycycline monohydrate 100 MG Oral CapsuleSCDfef9580d-8850-4cbb-89eb-2b4d40ee59c99
1649401doxycycline monohydrate 50 MG Oral CapsuleSCDfef9580d-8850-4cbb-89eb-2b4d40ee59c99
700408doxycycline monohydrate 75 MG Oral CapsuleSCDfef9580d-8850-4cbb-89eb-2b4d40ee59c99

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-706-0168382070601100 CAPSULE in 1 BOTTLE (68382-706-01) 100 capsule2016-03-140000-00-00NoNoCurrent
68382-706-0568382070605500 CAPSULE in 1 BOTTLE (68382-706-05) 500 capsule2016-03-140000-00-00NoNoCurrent
68382-706-066838207060630 CAPSULE in 1 BOTTLE (68382-706-06) 30 capsule2016-03-140000-00-00NoNoCurrent
68382-706-10683820706101000 CAPSULE in 1 BOTTLE (68382-706-10) 1000 capsule2016-03-140000-00-00NoNoCurrent
68382-706-166838207061690 CAPSULE in 1 BOTTLE (68382-706-16) 90 capsule2016-03-140000-00-00NoNoCurrent
68382-706-186838207061850 CAPSULE in 1 BOTTLE (68382-706-18) 50 capsule2016-03-140000-00-00NoNoCurrent
68382-706-306838207063010 in 1 BLISTER PACKHistorical
68382-706-776838207067710 BLISTER PACK in 1 CARTON (68382-706-77) / 10 CAPSULE in 1 BLISTER PACK (68382-706-30) 10 blister pack2016-03-140000-00-00NoNoCurrent