NDC 52959-692

misoprostol

Misoprostol

misoprostol is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Misoprostol.

• Product ID: 52959-692_9355aee3-c2a5-485f-ae95-cf93bfc0a57f
• NDC: 52959-692
• Product Type: Human Prescription Drug
• Proprietary Name: misoprostol
• Generic Name: Misoprostol
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2009-12-27
• Marketing Category: NDA / NDA
• Application Number: NDA019268
• Labeler Name: H.J. Harkins Company, Inc.
• Substance Name: MISOPROSTOL
• Active Ingredient Strength: 100 ug/1
• Pharm Classes: Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 52959-692-12

12 TABLET in 1 BOTTLE (52959-692-12)

• Marketing Start Date: 2009-12-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52959-692-28 [52959069228]

misoprostol TABLET

• Marketing Category: NDA
• Application Number: NDA019268
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-12-27
• Inactivation Date: 2019-11-13

NDC 52959-692-30 [52959069230]

misoprostol TABLET

• Marketing Category: NDA
• Application Number: NDA019268
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-12-27
• Inactivation Date: 2019-11-13

NDC 52959-692-60 [52959069260]

misoprostol TABLET

• Marketing Category: NDA
• Application Number: NDA019268
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-12-27
• Inactivation Date: 2019-11-13

NDC 52959-692-12 [52959069212]

misoprostol TABLET

• Marketing Category: NDA
• Application Number: NDA019268
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-12-27
• Inactivation Date: 2019-11-13

NDC 52959-692-40 [52959069240]

misoprostol TABLET

• Marketing Category: NDA
• Application Number: NDA019268
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-12-27
• Inactivation Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
MISOPROSTOL	100 ug/1

OpenFDA Data

• SPL SET ID: a5e5413d-bc22-4ae1-959b-0eb0430dbd38
• Manufacturer:
  • H.J. Harkins Company, Inc.
• UNII:
  • 0E43V0BB57
• RxNorm Concept Unique ID - RxCUI:
  • 311727

Pharmacological Class

• Prostaglandin E1 Analog [EPC]
• Prostaglandins E
• Synthetic [CS]

NDC Crossover Matching brand name "misoprostol" or generic name "Misoprostol"

NDC	Brand Name	Generic Name
0179-0218	Misoprostol	Misoprostol
0904-6806	Misoprostol	Misoprostol
0904-6807	Misoprostol	Misoprostol
10135-745	Misoprostol	Misoprostol
10135-746	Misoprostol	Misoprostol
12634-502	misoprostol	MISOPROSTOL
33261-076	Misoprostol	Misoprostol
33261-754	Misoprostol	Misoprostol
40032-160	Misoprostol	Misoprostol
40032-161	Misoprostol	Misoprostol
42571-253	MISOPROSTOL	Misoprostol
42571-254	MISOPROSTOL	Misoprostol
43063-707	Misoprostol	Misoprostol
43386-160	Misoprostol	Misoprostol
43386-161	Misoprostol	Misoprostol
43393-020	misoprostol	MISOPROSTOL
43393-022	Misoprostol	Misoprostol
43393-023	Misoprostol	Misoprostol
43393-203	Misoprostol	Misoprostol
50436-3172	Misoprostol	Misoprostol
52959-692	misoprostol	misoprostol
68084-040	Misoprostol	Misoprostol
68084-041	Misoprostol	Misoprostol
69189-0161	Misoprostol	Misoprostol
71335-0460	Misoprostol	Misoprostol
55154-4998	Misoprostol	Misoprostol
59762-5007	misoprostol	misoprostol
59762-5008	misoprostol	misoprostol
63704-008	Misoprostol	Misoprostol
64205-161	Misoprostol	Misoprostol
66336-608	misoprostol	misoprostol
68071-4843	Misoprostol	Misoprostol
63629-7929	Misoprostol	Misoprostol
54348-148	Misoprostol	Misoprostol
70710-1007	Misoprostol	Misoprostol
70771-1496	Misoprostol	Misoprostol
70771-1497	Misoprostol	Misoprostol
70710-1006	Misoprostol	Misoprostol
72789-121	Misoprostol	Misoprostol
72789-111	misoprostol	misoprostol
0025-1451	Cytotec	misoprostol
0025-1461	Cytotec	misoprostol
12634-933	CYTOTEC	MISOPROSTOL