NDC 54348-148

Misoprostol

Misoprostol

Misoprostol is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pharmpak, Inc.. The primary component is Misoprostol.

Product ID54348-148_90a11364-fc19-e94e-e053-2a95a90a9782
NDC54348-148
Product TypeHuman Prescription Drug
Proprietary NameMisoprostol
Generic NameMisoprostol
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-07-10
Marketing CategoryANDA / ANDA
Application NumberANDA091667
Labeler NamePharmPak, Inc.
Substance NameMISOPROSTOL
Active Ingredient Strength200 ug/1
Pharm ClassesProstaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 54348-148-00

1 BOTTLE in 1 BOX (54348-148-00) > 1 TABLET in 1 BOTTLE
Marketing Start Date2019-07-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54348-148-09 [54348014809]

Misoprostol TABLET
Marketing CategoryANDA
Application NumberANDA091667
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10

NDC 54348-148-06 [54348014806]

Misoprostol TABLET
Marketing CategoryANDA
Application NumberANDA091667
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10

NDC 54348-148-00 [54348014800]

Misoprostol TABLET
Marketing CategoryANDA
Application NumberANDA091667
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10

NDC 54348-148-03 [54348014803]

Misoprostol TABLET
Marketing CategoryANDA
Application NumberANDA091667
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10

NDC 54348-148-01 [54348014801]

Misoprostol TABLET
Marketing CategoryANDA
Application NumberANDA091667
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10

NDC 54348-148-04 [54348014804]

Misoprostol TABLET
Marketing CategoryANDA
Application NumberANDA091667
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10

NDC 54348-148-08 [54348014808]

Misoprostol TABLET
Marketing CategoryANDA
Application NumberANDA091667
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10

NDC 54348-148-02 [54348014802]

Misoprostol TABLET
Marketing CategoryANDA
Application NumberANDA091667
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10

Drug Details

Active Ingredients

IngredientStrength
MISOPROSTOL200 ug/1

OpenFDA Data

SPL SET ID:b07b3dfc-1cb5-484c-be11-8d14c89c794f
Manufacturer
UNII

Pharmacological Class

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

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

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