NDC 0299-3822

ORACEA

Doxycycline

ORACEA is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Galderma Laboratories, L.p.. The primary component is Doxycycline.

• Product ID: 0299-3822_a78ea97d-fa82-40b7-aa5c-0536b364cc69
• NDC: 0299-3822
• Product Type: Human Prescription Drug
• Proprietary Name: ORACEA
• Generic Name: Doxycycline
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2010-05-14
• Marketing Category: NDA / NDA
• Application Number: NDA050805
• Labeler Name: Galderma Laboratories, L.P.
• Substance Name: DOXYCYCLINE
• Active Ingredient Strength: 40 mg/1
• Pharm Classes: Tetracycline-class Drug [EPC], Tetracyclines [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2024-12-31

Packaging

NDC 0299-3822-02

12 TRAY in 1 BOX (0299-3822-02) > 8 CARTON in 1 TRAY > 1 BLISTER PACK in 1 CARTON > 2 CAPSULE in 1 BLISTER PACK

• Marketing Start Date: 2015-02-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0299-3822-07 [00299382207]

ORACEA CAPSULE

• Marketing Category: NDA
• Application Number: NDA050805
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-02-01

NDC 0299-3822-04 [00299382204]

ORACEA CAPSULE

• Marketing Category: NDA
• Application Number: NDA050805
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-05-14

NDC 0299-3822-30 [00299382230]

ORACEA CAPSULE

• Marketing Category: NDA
• Application Number: NDA050805
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-05-14

NDC 0299-3822-02 [00299382202]

ORACEA CAPSULE

• Marketing Category: NDA
• Application Number: NDA050805
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-02-01

NDC 0299-3822-05 [00299382205]

ORACEA CAPSULE

• Marketing Category: NDA
• Application Number: NDA050805
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-05-14

NDC 0299-3822-06 [00299382206]

ORACEA CAPSULE

• Marketing Category: NDA
• Application Number: NDA050805
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-05-14

Drug Details

Active Ingredients

Ingredient	Strength
DOXYCYCLINE	40 mg/1

OpenFDA Data

• SPL SET ID: aa15c93a-ff4c-447a-8a21-96da506d8997
• Manufacturer:
  • Galderma Laboratories, L.P.
• UNII:
  • N12000U13O
• RxNorm Concept Unique ID - RxCUI:
  • 901401
  • 901399
• PHarm Class EPC:
  • Tetracycline-class Drug [EPC]
• UPC Code:
  • 0302993822301
• NUI Code:
  • N0000007948
  • N0000175882

Pharmacological Class

• Tetracycline-class Drug [EPC]
• Tetracyclines [CS]

NDC Crossover Matching brand name "ORACEA" or generic name "Doxycycline"

NDC	Brand Name	Generic Name
0299-3822	ORACEA	DOXYCYCLINE
0115-1327	Doxycycline	Doxycycline
0143-9381	Doxycycline	Doxycycline
0179-0129	Doxycycline	Doxycycline
0378-5475	Doxycycline	doxycycline
0378-6021	Doxycycline	Doxycycline
0378-6022	Doxycycline	Doxycycline
0378-6023	Doxycycline	Doxycycline
0378-6124	Doxycycline	Doxycycline
0404-9855	DOXYCYCLINE	doxycycline
0527-1335	Doxycycline	Doxycycline
0527-1338	Doxycycline	Doxycycline
0527-1535	Doxycycline	Doxycycline
0527-1537	Doxycycline	Doxycycline
0378-0145	doxycycline hyclate	doxycycline
0378-0148	doxycycline hyclate	doxycycline
0378-0167	doxycycline hyclate	doxycycline
0069-0970	Vibramycin Monohydrate	doxycycline