Procto-Pak

Product NDC: 64980-302
11-digit product format: 649800302
Labeler code: 64980
Product ID: 64980-302_384f2adf-43c5-410b-8a1e-d856ac3d8a17
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrocortisone
Dosage form: CREAM
Route: TOPICAL
Labeler: Rising Pharmaceuticals, Inc.
Application: ANDA087795
Marketing category: ANDA
Marketing start: 2012-06-01
Marketing end: 0000-00-00
Substance: HYDROCORTISONE
Active strength: 10 mg/g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64980-302-30	2024-03-12	C162847	48780-1	d6a99b39-68dd-a426-e053-dadaa90af4c2	a1148e9e-061c-4070-8059-68ffe3d3b20a
64980-302-30	2022-01-28	C162847	48780-1	d6a99b39-68dd-a426-e053-dadaa90af4c2	a1148e9e-061c-4070-8059-68ffe3d3b20a

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64980-302-30	GM - Gram	64980-302	b22acfda-29af-4efe-a9c4-7e5f02c27c04	1	2012-07-24

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WI4X0X7BPJ	HYDROCORTISONE	50-23-7	HYDROCORTISONE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64980-302-30	64980030230	1 TUBE in 1 CARTON (64980-302-30) > 28 g in 1 TUBE	1 tube	2012-06-01	0000-00-00	No	No	Current