Naproxen

Product NDC: 71335-1869
11-digit product format: 713351869
Labeler code: 71335
Product ID: 71335-1869_3f020a02-71fd-4194-abac-d29da8af014b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA212517
Marketing category: ANDA
Marketing start: 2020-03-01
Substance: NAPROXEN
Active strength: 250 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Related Records

UNII	Preferred term	Registry number	Matched term
57Y76R9ATQ	NAPROXEN	22204-53-1	NAPROXEN

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-1869-1	71335186901	30 TABLET in 1 BOTTLE (71335-1869-1)	30 tablet	2021-06-21	No	No	Historical
71335-1869-2	71335186902	60 TABLET in 1 BOTTLE (71335-1869-2)	60 tablet	2021-06-21	No	No	Historical
71335-1869-3	71335186903	20 TABLET in 1 BOTTLE (71335-1869-3)	20 tablet	2021-06-21	No	No	Historical
71335-1869-4	71335186904	120 TABLET in 1 BOTTLE (71335-1869-4)	120 tablet	2021-06-21	No	No	Historical
71335-1869-5	71335186905	10 TABLET in 1 BOTTLE (71335-1869-5)	10 tablet	2021-06-21	No	No	Historical
71335-1869-6	71335186906	90 TABLET in 1 BOTTLE (71335-1869-6)	90 tablet	2021-06-21	No	No	Historical
71335-1869-7	71335186907	40 TABLET in 1 BOTTLE (71335-1869-7)	40 tablet	2021-06-21	No	No	Historical
71335-1869-8	71335186908	45 TABLET in 1 BOTTLE (71335-1869-8)	45 tablet	2021-06-21	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Naproxen	Bryant Ranch Prepack	2026-05-15	HUMAN PRESCRIPTION DRUG LABEL	106