DOXYCYCLINE

Product NDC
11788-134
11-digit product format
117880134
Labeler code
11788
Product ID
11788-134_ed0afbd5-2f21-48d3-a1a2-a253b4ad707a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE
Dosage form
CAPSULE
Route
ORAL
Labeler
AiPing Pharmaceutical, Inc.
Application
ANDA219978
Marketing category
ANDA
Marketing start
2026-01-16
Substance
DOXYCYCLINE
Active strength
40 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 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
A219978-001DOXYCYCLINEDOXYCYCLINE40MGCAPSULE / ORALAB2025-10-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219978-001AB

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 22:38:342026-08A219978-001DOXYCYCLINE40MGCAPSULE / ORALAB2025-10-0184e616aacf4f…
2026-08-18 06:07:402026-07A219978-001DOXYCYCLINE40MGCAPSULE / ORALAB2025-10-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219978-001DOXYCYCLINE40MGCAPSULE / ORALAB2025-10-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219978-001DOXYCYCLINE40MGCAPSULE / ORALAB2025-10-0131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219978-001DOXYCYCLINE40MGCAPSULE / ORALAB2025-10-01a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A219978-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A219978-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219978-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219978-001AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219978-001AB1a50c72e98297…

Additional Listing Data#

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

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
a894f4be-19e5-4785-8d0b-5e0d5626300eAvailable 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
11788-134-30DOXYCYCLINE30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11788-134-30EA - Each11788-134add914f5-a0fb-45c4-9b10-b80c5eb3658212026-03-17

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOXYCYCLINEDOXYCYCLINEAiPing Pharmaceutical, Inc.a894f4be-19e5-4785-8d0b-5e0d5626300e2026-01-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219978
application number: ANDA219978
ndc (product): 11788-134

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
901399doxycycline anhydrous 40 MG Delayed Release Oral CapsulePSNa894f4be-19e5-4785-8d0b-5e0d5626300e1
901399doxycycline anhydrous 40 MG Delayed Release Oral CapsuleSCDa894f4be-19e5-4785-8d0b-5e0d5626300e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11788-134-301178801343030 CAPSULE in 1 BOTTLE (11788-134-30) 30 capsule2026-01-16NoNoCurrent