Carbamazepine

Product NDC: 70518-3176
11-digit product format: 705183176
Labeler code: 70518
Product ID: 70518-3176_c833e685-b6f8-5cf3-e053-2a95a90a1788
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbamazepine
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA078986
Marketing category: ANDA
Marketing start: 2021-07-28
Marketing end: 0000-00-00
Substance: CARBAMAZEPINE
Active strength: 200 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-3176-0	2023-03-20	C162847	48780-1	f386c64a-14b3-0266-e053-dadaa90a7c1a	23394995-a161-43ac-84b6-d14914cac6a8
70518-3176-0	2023-01-30	C162847	48780-1	f386c64a-14b3-0266-e053-dadaa90a7c1a	23394995-a161-43ac-84b6-d14914cac6a8

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
33CM23913M	CARBAMAZEPINE	298-46-4	CARBAMAZEPINE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3176-0	70518317600	30 POUCH in 1 BOX (70518-3176-0) > 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-3176-1)	30 pouch	2021-07-28	0000-00-00	No	No	Current