Home NDC 0299-3822-07 ORACEA
Product NDC 0299-3822
Requested package NDC 0299-3822-07
11-digit product format 002993822
Labeler code 0299
Product ID 0299-3822_67eef1b6-593a-4277-abd3-f3e60e7557b0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DOXYCYCLINE
Dosage form CAPSULE
Route ORAL
Labeler Galderma Laboratories, L.P.
Application NDA050805
Marketing category NDA
Marketing start 2010-05-14
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 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050805-001 ORACEA DOXYCYCLINE 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050805-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N050805-001 7749532 2027-12-19 U-1063 Drug product
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N050805-001 AB 1 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N050805-001 7749532 2027-12-19 U-1063 Drug product a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base ORACEA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXYCYCLINE 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N12000U13O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 901399 Internal RxNorm lookup 901401 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOXYCYCLINE ACTIVE INGREDIENT N12000U13O ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.] 10 DOXYCYCLINE ANHYDROUS ACTIVE MOIETY 334895S862 ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.] 10 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.] 10 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.] 10 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.] 10 METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A INACTIVE INGREDIENT NX76LV5T8J ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.] 10 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.] 10 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.] 10 SUCROSE INACTIVE INGREDIENT C151H8M554 ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.] 10 TALC INACTIVE INGREDIENT 7SEV7J4R1U ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.] 10 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0299-3822 ORACEA (DOXYCYCLINE) CAPSULE [GALDERMA LABORATORIES, L.P.] 19 Current NDC, Legacy NDC, 10 package rows 20250417_aa15c93a-ff4c-447a-8a21-96da506d8997.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0299-3822-07 00299382207 24 TRAY in 1 BOX (0299-3822-07) > 4 CARTON in 1 TRAY > 1 BLISTER PACK in 1 CARTON > 2 CAPSULE in 1 BLISTER PACK 24 tray 2015-02-01 0000-00-00 No No Current