DOXYCYCLINE

Product NDC
62332-785
11-digit product format
623320785
Labeler code
62332
Product ID
62332-785_c89c0388-cc32-4fa4-a954-678d7448d4c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA217674
Marketing category
ANDA
Marketing start
2024-06-27
Substance
DOXYCYCLINE
Active strength
40 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217674-001DOXYCYCLINEDOXYCYCLINE40MGCAPSULE / ORALAB2024-06-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217674-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A217674-001DOXYCYCLINE40MGCAPSULE / ORALAB2024-06-2784e616aacf4f…
2026-08-18 06:07:402026-07A217674-001DOXYCYCLINE40MGCAPSULE / ORALAB2024-06-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217674-001DOXYCYCLINE40MGCAPSULE / ORALAB2024-06-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217674-001DOXYCYCLINE40MGCAPSULE / ORALAB2024-06-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A217674-001DOXYCYCLINE40MGCAPSULE / ORALAB2024-06-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217674-001DOXYCYCLINE40MGCAPSULE / ORALAB2024-06-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217674-001DOXYCYCLINE40MGCAPSULE / ORALAB2024-06-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217674-001DOXYCYCLINE40MGCAPSULE / ORALAB2024-06-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217674-001DOXYCYCLINE40MGCAPSULE / ORALAB2024-06-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217674-001DOXYCYCLINE40MGCAPSULE / ORALAB2024-06-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217674-001DOXYCYCLINE40MGCAPSULE / ORALAB2024-06-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217674-001DOXYCYCLINE40MGCAPSULE / ORALAB2024-06-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217674-001DOXYCYCLINE40MGCAPSULE / ORALAB2024-06-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217674-001DOXYCYCLINE40MGCAPSULE / ORALAB2024-06-27301d65b070ca…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217674-001DOXYCYCLINE40MGCAPSULE / ORALAB2024-06-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A217674-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A217674-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217674-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217674-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217674-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217674-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217674-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217674-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217674-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217674-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217674-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217674-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217674-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217674-001AB1301d65b070ca…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217674-001AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE40 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
901399Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a50e953d-447b-4b66-b567-04586174d3f9Available 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
62332-785-30DOXYCYCLINE30 in 1 BOTTLECAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-785-30EA - Each62332-785374beb4f-a157-4933-8128-39d7d157c19112024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-785DOXYCYCLINE CAPSULE [ALEMBIC PHARMACEUTICALS INC.]3Current NDC, 1 package rows20240702_a50e953d-447b-4b66-b567-04586174d3f9.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
DOXYCYCLINEDOXYCYCLINEAlembic Pharmaceuticals Inc.a50e953d-447b-4b66-b567-04586174d3f92025-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217674
application number: ANDA217674
ndc (product): 62332-785
DOXYCYCLINEDOXYCYCLINEAlembic Pharmaceuticals Limited8e78dc54-8322-435d-8879-4bfe37f1b98c2024-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217674
application number: ANDA217674

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
901399doxycycline anhydrous 40 MG Delayed Release Oral CapsulePSNa50e953d-447b-4b66-b567-04586174d3f94
901399doxycycline anhydrous 40 MG Delayed Release Oral CapsuleSCDa50e953d-447b-4b66-b567-04586174d3f94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62332-785-306233207853030 CAPSULE in 1 BOTTLE (62332-785-30) 30 capsule2024-06-27NoNoCurrent