CARBAMAZEPINE

Product NDC: 51655-017
11-digit product format: 516550017
Labeler code: 51655
Product ID: 51655-017_68b0341d-59e4-43c1-a1c4-71b7907d6e3e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CARBAMAZEPINE
Dosage form: TABLET
Route: ORAL
Labeler: Northwind Pharmaceuticals, LLC
Application: ANDA075948
Marketing category: ANDA
Marketing start: 2015-03-03
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: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
26452c40-1589-928d-2fae-b84a1d1cf183	Product name	9	20251105
2275add5-bc9e-431c-8e27-74c11f3127d5	Product name	1	20200728
7c710123-0208-426b-be07-b37720f2767d	Product name	1	20161206
8448f819-8511-2a70-1d0e-32e16eac918d	Product name	1	20140508
fee3eefd-cade-4e53-89b7-9d28964e1bc7	Product name	1	20140508

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51655-017-92	2026-01-08	C162847	48780-1	9d75b9d0-e17f-f424-e053-dadaa90a57ce	CARBAMAZEPINE
51655-017-92	2020-01-31	C162847	48780-1	9d75b9d0-e17f-f424-e053-dadaa90a57ce	CARBAMAZEPINE

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
CARBAMAZEPINE	ACTIVE INGREDIENT	33CM23913M	CARBAMAZEPINE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1
CARBAMAZEPINE	ACTIVE MOIETY	33CM23913M	CARBAMAZEPINE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-017	CARBAMAZEPINE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1	Legacy NDC	20150323_8e5df2e3-92fc-4865-97de-1da0a32c788d.zip