NDC 52584-028

Doxy 100

Doxycycline

Doxy 100 is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc. The primary component is Doxycycline Hyclate.

• Product ID: 52584-028_714ce832-e99d-4bd5-9e83-d4ce3c5db7b2
• NDC: 52584-028
• Product Type: Human Prescription Drug
• Proprietary Name: Doxy 100
• Generic Name: Doxycycline
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2012-02-22
• Marketing Category: ANDA / ANDA
• Application Number: ANDA062475
• Labeler Name: General Injectables & Vaccines, Inc
• Substance Name: DOXYCYCLINE HYCLATE
• Active Ingredient Strength: 100 mg/10mL
• Pharm Classes: Tetracycline-class Drug [EPC],Tetracyclines [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 52584-028-11

1 VIAL in 1 BAG (52584-028-11) > 10 mL in 1 VIAL

• Marketing Start Date: 2018-08-03
• Marketing End Date: 2021-09-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52584-028-11 [52584002811]

Doxy 100 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA062475
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-08-03
• Marketing End Date: 2021-09-30

Drug Details

Active Ingredients

Ingredient	Strength
DOXYCYCLINE HYCLATE	100 mg/10mL

OpenFDA Data

• SPL SET ID: 5df74bff-1e68-460c-8327-ee7ffd2471e8
• Manufacturer:
  • General Injectables & Vaccines, Inc
• UNII:
  • 19XTS3T51U
• RxNorm Concept Unique ID - RxCUI:
  • 544840
  • 310027

Pharmacological Class

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

NDC Crossover Matching brand name "Doxy 100" or generic name "Doxycycline"

NDC	Brand Name	Generic Name
52584-028	Doxy 100	Doxy 100
63323-130	Doxy 100	Doxy 100
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
0299-3822	ORACEA	DOXYCYCLINE
0069-0970	Vibramycin Monohydrate	doxycycline