NDC 55056-0818

Crinone

Progesterone

Crinone is a Vaginal Gel in the Human Prescription Drug category. It is labeled and distributed by Columbia Laboratories, Inc.. The primary component is Progesterone.

• Product ID: 55056-0818_f2c9bbef-22b9-413b-930d-e84fbea8247b
• NDC: 55056-0818
• Product Type: Human Prescription Drug
• Proprietary Name: Crinone
• Generic Name: Progesterone
• Dosage Form: Gel
• Route of Administration: VAGINAL
• Marketing Start Date: 1997-05-13
• Marketing Category: NDA / NDA
• Application Number: NDA020701
• Labeler Name: Columbia Laboratories, Inc.
• Substance Name: PROGESTERONE
• Active Ingredient Strength: 90 mg/1.125g
• Pharm Classes: Progesterone [CS],Progesterone [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 55056-0818-2

18 APPLICATOR in 1 CARTON (55056-0818-2) > 1.125 g in 1 APPLICATOR

• Marketing Start Date: 1997-05-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55056-0818-5 [55056081805]

Crinone GEL

• Marketing Category: NDA
• Application Number: NDA020701
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1997-05-13
• Inactivation Date: 2019-10-21

NDC 55056-0818-2 [55056081802]

Crinone GEL

• Marketing Category: NDA
• Application Number: NDA020701
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1997-05-13
• Inactivation Date: 2019-10-21

NDC 55056-0818-9 [55056081809]

Crinone GEL

• Marketing Category: NDA
• Application Number: NDA020701
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1997-05-13
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
PROGESTERONE	90 mg/1.125g

OpenFDA Data

• SPL SET ID: 2c8ffbd2-6b7a-42c7-b29e-e4de69dad9e6
• Manufacturer:
  • Columbia Laboratories, Inc.
• UNII:
  • 4G7DS2Q64Y
• RxNorm Concept Unique ID - RxCUI:
  • 153579
  • 153580
  • 312645
  • 312643

Pharmacological Class

• Progesterone [CS]
• Progesterone [EPC]

NDC Crossover Matching brand name "Crinone" or generic name "Progesterone"

NDC	Brand Name	Generic Name
0023-6150	Crinone	progesterone
0023-6151	Crinone	progesterone
52544-255	Crinone	progesterone
52544-256	Crinone	progesterone
55056-0806	Crinone	Crinone
55056-0808	Crinone	Crinone
55056-0818	Crinone	Crinone
43857-0084	Natural Progesterone	Progesterone
0093-5353	Progesterone	Progesterone
0093-5354	Progesterone	Progesterone
0143-9725	Progesterone	Progesterone
0517-0750	Progesterone	Progesterone
0591-3128	PROGESTERONE	PROGESTERONE
10888-7135	PROGESTERONE	PROGESTERONE
10888-7136	PROGESTERONE	PROGESTERONE
16714-157	Progesterone	Progesterone
16714-158	Progesterone	Progesterone
17478-766	Progesterone	Progesterone
17478-767	Progesterone	Progesterone
42291-690	PROGESTERONE	PROGESTERONE
43598-349	Progesterone	Progesterone
43598-350	Progesterone	Progesterone
43742-0158	Progesterone	Progesterone
43742-0762	Progesterone	Progesterone
43742-0851	Progesterone	Progesterone
43857-0103	Progesterone	Progesterone
43857-0120	Progesterone	Progesterone
50090-2325	PROGESTERONE	PROGESTERONE
50090-2527	Progesterone	Progesterone
50090-3240	Progesterone	Progesterone
50090-4656	Progesterone	Progesterone
50090-5928	Progesterone	Progesterone
44911-0047	Progesterone Phenolic	Progesterone