GABAPENTIN

Product NDC: 61919-102
11-digit product format: 619190102
Labeler code: 61919
Product ID: 61919-102_7d9af18b-1edc-4f6b-a4aa-5cca7652b600
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GABAPENTIN
Dosage form: CAPSULE
Route: ORAL
Labeler: Direct Rx
Application: ANDA077242
Marketing category: ANDA
Marketing start: 2015-01-01
Marketing end: 0000-00-00
Substance: GABAPENTIN
Active strength: 300 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cdc2ae60-922e-452d-a42f-787fe4e2ed06	Product name	1	20250123
7059096a-4b9f-36c2-db50-bb5c723e6e9e	Product name	2	20250114
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
fa3f0129-3502-889f-f424-3a37727959e7	Product name	9	20181206
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
77d89e4c-f57f-326d-d7aa-787f8eebbd2b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-102-71	2020-01-31	C162847	48780-1	9d75b9d0-a68a-f424-e053-dadaa90a57ce	Gabapentin
61919-102-72	2020-01-31	C162847	48780-1	9d75b9d0-7987-f424-e053-dadaa90a57ce	GABAPENTIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-102-30	GABAPENTIN	30 in 1 BOTTLE	CAPSULE	30	2
61919-102-60	GABAPENTIN	60 in 1 BOTTLE	CAPSULE	60	2
61919-102-72	GABAPENTIN	120 in 1 BOTTLE	CAPSULE	120	2
61919-102-90	GABAPENTIN	90 in 1 BOTTLE	CAPSULE	90	2
61919-102-71	Gabapentin	100 in 1 BOTTLE	Capsule	100	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-102-30	EA - Each	61919-102	5fe071c5-fbed-45c3-ba66-c2a71c5693ee	1	2014-05-02
61919-102-60	EA - Each	61919-102	003af925-1410-4989-a13c-ffe9058880c9	1	2014-05-02
61919-102-72	EA - Each	61919-102	83133469-9868-4a43-80d0-87c0d8bd4998	1	2014-05-02
61919-102-90	EA - Each	61919-102	cbac1060-243c-4ad5-8d21-c5037c89eae7	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [DIRECT RX]	2
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [DIRECT RX]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	GABAPENTIN CAPSULE [DIRECT RX]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	GABAPENTIN CAPSULE [DIRECT RX]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	GABAPENTIN CAPSULE [DIRECT RX]	2
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	GABAPENTIN CAPSULE [DIRECT RX]	2
CALCIUM SULFATE DIHYDRATE	INACTIVE INGREDIENT	4846Q921YM	GABAPENTIN CAPSULE [DIRECT RX]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GABAPENTIN CAPSULE [DIRECT RX]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN CAPSULE [DIRECT RX]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GABAPENTIN CAPSULE [DIRECT RX]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE [DIRECT RX]	2
GLYCERYL BEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	GABAPENTIN CAPSULE [DIRECT RX]	2
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	GABAPENTIN CAPSULE [DIRECT RX]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	GABAPENTIN CAPSULE [DIRECT RX]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	GABAPENTIN CAPSULE [DIRECT RX]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GABAPENTIN CAPSULE [DIRECT RX]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GABAPENTIN CAPSULE [DIRECT RX]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	GABAPENTIN CAPSULE [DIRECT RX]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [DIRECT RX]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [DIRECT RX]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	GABAPENTIN CAPSULE [DIRECT RX]	2
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [DIRECT RX]	1
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [DIRECT RX]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	GABAPENTIN CAPSULE [DIRECT RX]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	GABAPENTIN CAPSULE [DIRECT RX]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	GABAPENTIN CAPSULE [DIRECT RX]	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	GABAPENTIN CAPSULE [DIRECT RX]	1
CALCIUM SULFATE DIHYDRATE	INACTIVE INGREDIENT	4846Q921YM	GABAPENTIN CAPSULE [DIRECT RX]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN CAPSULE [DIRECT RX]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GABAPENTIN CAPSULE [DIRECT RX]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE [DIRECT RX]	1
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	GABAPENTIN CAPSULE [DIRECT RX]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	GABAPENTIN CAPSULE [DIRECT RX]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	GABAPENTIN CAPSULE [DIRECT RX]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GABAPENTIN CAPSULE [DIRECT RX]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GABAPENTIN CAPSULE [DIRECT RX]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	GABAPENTIN CAPSULE [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [DIRECT RX]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	GABAPENTIN CAPSULE [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-102	GABAPENTIN CAPSULE [DIRECT RX]	2	Legacy NDC, 4 package rows	20150814_52e49778-03f1-43cb-b75d-6c1adbb96ec6.zip
61919-102	GABAPENTIN CAPSULE [DIRECT RX]	1	Legacy NDC, 1 package rows	20150822_0c214cba-66d8-46e0-9632-84f10b2ca5a4.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6CW7F3G59X	GABAPENTIN	60142-96-3	GABAPENTIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310430	gabapentin 100 MG Oral Capsule	PSN	52e49778-03f1-43cb-b75d-6c1adbb96ec6	2
310431	gabapentin 300 MG Oral Capsule	PSN	52e49778-03f1-43cb-b75d-6c1adbb96ec6	2
310432	gabapentin 400 MG Oral Capsule	PSN	52e49778-03f1-43cb-b75d-6c1adbb96ec6	2
310430	gabapentin 100 MG Oral Capsule	SCD	52e49778-03f1-43cb-b75d-6c1adbb96ec6	2
310431	gabapentin 300 MG Oral Capsule	SCD	52e49778-03f1-43cb-b75d-6c1adbb96ec6	2
310432	gabapentin 400 MG Oral Capsule	SCD	52e49778-03f1-43cb-b75d-6c1adbb96ec6	2
310431	gabapentin 300 MG Oral Capsule	PSN	0c214cba-66d8-46e0-9632-84f10b2ca5a4	1
310431	gabapentin 300 MG Oral Capsule	SCD	0c214cba-66d8-46e0-9632-84f10b2ca5a4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
61919-102-30	61919010230	30 in 1 BOTTLE	Historical
61919-102-60	61919010260	60 in 1 BOTTLE	Historical
61919-102-71	61919010271	100 in 1 BOTTLE	Historical
61919-102-72	61919010272	120 in 1 BOTTLE	Historical
61919-102-90	61919010290	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	Direct Rx	2015-08-21	HUMAN PRESCRIPTION DRUG LABEL	1
GABAPENTIN	Direct Rx	2015-08-13	HUMAN PRESCRIPTION DRUG LABEL	2

GABAPENTIN

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#