Promethazine Hydrochloride

Product NDC: 0781-1832
11-digit product format: 007811832
Labeler code: 0781
Product ID: 0781-1832_6917d220-8289-4719-bfee-f6e6d201ed12
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA084176
Marketing category: ANDA
Marketing start: 1975-02-18
Marketing end: 0000-00-00
Substance: PROMETHAZINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0781-1832-01	2020-08-18	C162847	48780-1	ab0e2407-297d-f274-e053-dbdaa90a6471	24086b53-a85c-443e-ad85-c1295ddf23c7
0781-1832-01	2020-07-22	C162847	48780-1	ab0e2407-297d-f274-e053-dbdaa90a6471	24086b53-a85c-443e-ad85-c1295ddf23c7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-1832-01	EA - Each	0781-1832	3a03a199-791b-49a6-917c-73d2b3d332bc	1	2012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-1832-01	00781183201	100 TABLET in 1 BOTTLE (0781-1832-01)	100 tablet	1975-02-18	0000-00-00	No	No	Current