DILAUDID

Product NDC: 70399-102
11-digit product format: 703990102
Labeler code: 70399
Product ID: 70399-102_260324cf-7851-4d90-ab35-5f71bc5104b0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydromorphone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: V1 Pharma Llc
Application: ANDA076723
Marketing category: ANDA
Marketing start: 2017-08-20
Marketing end: 0000-00-00
Substance: HYDROMORPHONE HYDROCHLORIDE
Active strength: 8 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c92985da-a658-b186-e763-2287eda87a86	Product name	3	20250221
96c475b3-58c7-b955-d715-0111804a3e50	Product name	5	20210512
1dd54659-b775-4fa8-a858-7f0e521fbadc	Product name	4	20200925

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70399-102-50	2020-01-31	C162847	48780-1	9d75b9d0-e3fb-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Hydromorphone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Hydromorphone Hydrochloride Tablets, USP. Hydromorphone Hydrochloride Tablets, USP, for oral use, C-II Initial U.S. Approval:1984 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70399-102-50	DILAUDID	100 in 1 BOTTLE	TABLET	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70399-102	DILAUDID (HYDROMORPHONE HYDROCHLORIDE) TABLET [V1 PHARMA LLC]	1	Legacy NDC, 1 package rows	20170901_3129ab18-7cd8-4c65-b3b1-ed0c8c1fdc00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
897712	DILAUDID 8 MG Oral Tablet	PSN	3129ab18-7cd8-4c65-b3b1-ed0c8c1fdc00	1
897710	HYDROmorphone HCl 8 MG Oral Tablet	PSN	3129ab18-7cd8-4c65-b3b1-ed0c8c1fdc00	1
897712	hydromorphone hydrochloride 8 MG Oral Tablet [Dilaudid]	SBD	3129ab18-7cd8-4c65-b3b1-ed0c8c1fdc00	1
897710	hydromorphone hydrochloride 8 MG Oral Tablet	SCD	3129ab18-7cd8-4c65-b3b1-ed0c8c1fdc00	1
897712	Dilaudid 8 MG Oral Tablet	SY	3129ab18-7cd8-4c65-b3b1-ed0c8c1fdc00	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
70399-102-50	70399010250	100 in 1 BOTTLE	Historical