GABAPENTIN

Product NDC: 61919-104
11-digit product format: 619190104
Labeler code: 61919
Product ID: 61919-104_786f7004-ac38-4b10-b5b7-cf63c199f0c0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GABAPENTIN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DIRECT RX
Application: ANDA078926
Marketing category: ANDA
Marketing start: 2014-01-01
Marketing end: 0000-00-00
Substance: GABAPENTIN
Active strength: 800 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
fa3f0129-3502-889f-f424-3a37727959e7	Product name	9	20181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2b	Product name	1	20140508

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-104-30	2020-01-31	C162847	48780-1	9d75b9d0-a70e-f424-e053-dadaa90a57ce	GABAPENTIN
61919-104-60	2020-01-31	C162847	48780-1	9d75b9d0-a70e-f424-e053-dadaa90a57ce	GABAPENTIN
61919-104-90	2020-01-31	C162847	48780-1	9d75b9d0-a70e-f424-e053-dadaa90a57ce	GABAPENTIN

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-104-30	GABAPENTIN	30 in 1 BOTTLE	TABLET, FILM COATED	30	2
61919-104-60	GABAPENTIN	60 in 1 BOTTLE	TABLET, FILM COATED	60	2
61919-104-90	GABAPENTIN	90 in 1 BOTTLE	TABLET, FILM COATED	90	2

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-104-30	EA - Each	61919-104	248f7bfd-4fc3-4ecf-a3da-fc23a3699ed6	1	2015-10-02
61919-104-60	EA - Each	61919-104	01d27d5b-dbfb-42a5-a9a3-3cec30256d8c	1	2015-10-02
61919-104-90	EA - Each	61919-104	9c767c13-8695-4c16-81fc-0159236e73fc	1	2014-06-03

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN TABLET, FILM COATED [DIRECT RX]	2
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN TABLET, FILM COATED [DIRECT RX]	2
COPOVIDONE	INACTIVE INGREDIENT	D9C330MD8B	GABAPENTIN TABLET, FILM COATED [DIRECT RX]	2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	GABAPENTIN TABLET, FILM COATED [DIRECT RX]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN TABLET, FILM COATED [DIRECT RX]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	GABAPENTIN TABLET, FILM COATED [DIRECT RX]	2
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	GABAPENTIN TABLET, FILM COATED [DIRECT RX]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	GABAPENTIN TABLET, FILM COATED [DIRECT RX]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN TABLET, FILM COATED [DIRECT RX]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-104	GABAPENTIN TABLET, FILM COATED [DIRECT RX]	2	Legacy NDC, 3 package rows	20151104_5b64e806-596f-4ebf-9dfa-e93ea5470c2f.zip

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310434	gabapentin 800 MG Oral Tablet	PSN	5b64e806-596f-4ebf-9dfa-e93ea5470c2f	2
310434	gabapentin 800 MG Oral Tablet	SCD	5b64e806-596f-4ebf-9dfa-e93ea5470c2f	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
61919-104-30	61919010430	30 in 1 BOTTLE	Historical
61919-104-60	61919010460	60 in 1 BOTTLE	Historical
61919-104-90	61919010490	90 in 1 BOTTLE	Historical