GABAPENTIN TABLETS

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-11-30
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-05-31 21:18:25

Label at a glance#

ProductGabapentin

Active ingredientGABAPENTIN

Label structure2 sections

Label contents#

Full prescribing information#

SPL MEDGUIDE SECTION

Manufactured by:

Cadila Heathcare Ltd.

India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-705-01 in bottle of 100 tablets

Gabapentin Tablets USP, 600 mg

R_xonly

100 tablets

NDC 65841-706-01 in bottle of 100 tablets

Gabapentin Tablets USP, 800 mg

R_xonly

100 tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310433	gabapentin 600 MG Oral Tablet	PSN	8
310434	gabapentin 800 MG Oral Tablet	PSN	8
310433	gabapentin 600 MG Oral Tablet	SCD	8
310434	gabapentin 800 MG Oral Tablet	SCD	8

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
GABAPENTIN Pharmacologic Class Indexing	4	Indexing - Pharmacologic Class	20230427

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65841-705-01	Gabapentin	100 in 1 BOTTLE	TABLET, FILM COATED	100	8
65841-705-05	Gabapentin	500 in 1 BOTTLE	TABLET, FILM COATED	500	8
65841-705-10	Gabapentin	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	8
65841-706-01	Gabapentin	100 in 1 BOTTLE	TABLET, FILM COATED	100	8
65841-706-05	Gabapentin	500 in 1 BOTTLE	TABLET, FILM COATED	500	8
65841-706-10	Gabapentin	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	8
65841-706-77	Gabapentin	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	8
65841-706-77	Gabapentin	10 in 1 CARTON	TABLET, FILM COATED	10	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65841-705	GABAPENTIN TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	8	Current NDC, Legacy NDC, 3 package rows	20241201_b033c169-4943-4ad9-ace0-7e4a1f0dc100.zip
65841-706	GABAPENTIN TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	8	Current NDC, Legacy NDC, 5 package rows	20241201_b033c169-4943-4ad9-ace0-7e4a1f0dc100.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	1
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	1
COPOVIDONE	INACTIVE INGREDIENT	D9C330MD8B	1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

Gabapentin
COPOVIDONE K25-31
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
MAGNESIUM STEARATE
MANNITOL
POLOXAMER 407
POVIDONE
TALC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65841-705	65841-705-01, 65841-705-05, 65841-705-10
65841-706	65841-706-01, 65841-706-05, 65841-706-10, 65841-706-77

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GABAPENTIN	6CW7F3G59X	ACTIB
COPOVIDONE K25-31	D9C330MD8B	IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	2165RE0K14	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MANNITOL	3OWL53L36A	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
POVIDONE	FZ989GH94E	IACT
TALC	7SEV7J4R1U	IACT
GABAPENTIN	6CW7F3G59X	ACTIB
COPOVIDONE K25-31	D9C330MD8B	IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	2165RE0K14	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MANNITOL	3OWL53L36A	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
POVIDONE	FZ989GH94E	IACT
TALC	7SEV7J4R1U	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 117 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii+route 63 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE, DELAYED RELEASE / ORAL		5 mg	Exact identifier — unii+route 63 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, FILM COATED / ORAL		2309 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, FILM COATED / ORAL		2309 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SUSPENSION / ORAL		10 mg	Exact identifier — unii+route 63 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	POWDER, FOR SUSPENSION / ORAL	0.01 mg		Exact identifier — unii+route 63 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE, DELAYED RELEASE / ORAL		5 mg	Exact identifier — unii+route 63 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SOLUTION / ORAL	50 mg/5ml		Exact identifier — unii+route 63 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SOLUTION / ORAL	50 mg/5ml		Exact identifier — unii+route 63 equally ranked IID candidates
COPOVIDONE	COPOVIDONE K25-31	D9C330MD8B	TABLET, FILM COATED / ORAL		5917 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SOLUTION / ORAL	50 mg/5ml		Exact identifier — unii+route 63 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SUSPENSION / ORAL		10 mg	Exact identifier — unii+route 63 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE	2165RE0K14	TABLET, FILM COATED / ORAL		40 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE, DELAYED RELEASE / ORAL		5 mg	Exact identifier — unii+route 63 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii+route 63 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
COPOVIDONE	COPOVIDONE K25-31	D9C330MD8B	TABLET, FILM COATED / ORAL		5917 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE / ORAL		468 mg	Exact identifier — unii+route 63 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	POWDER, FOR SUSPENSION / ORAL	0.01 mg		Exact identifier — unii+route 63 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SOLUTION / ORAL	50 mg/5ml		Exact identifier — unii+route 63 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii+route 63 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii+route 63 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii+route 63 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE	2165RE0K14	TABLET, FILM COATED / ORAL		40 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE / ORAL		468 mg	Exact identifier — unii+route 63 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE / ORAL		468 mg	Exact identifier — unii+route 63 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE / ORAL		468 mg	Exact identifier — unii+route 63 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii+route 63 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE	2165RE0K14	TABLET, FILM COATED / ORAL		40 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	POWDER, FOR SUSPENSION / ORAL	0.01 mg		Exact identifier — unii+route 63 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SUSPENSION / ORAL		10 mg	Exact identifier — unii+route 63 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE	2165RE0K14	TABLET, FILM COATED / ORAL		40 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE	2165RE0K14	TABLET, FILM COATED / ORAL		40 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii+route 63 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE, DELAYED RELEASE / ORAL		5 mg	Exact identifier — unii+route 63 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE	2165RE0K14	TABLET, FILM COATED / ORAL		40 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, FILM COATED / ORAL		2309 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	POWDER, FOR SUSPENSION / ORAL	0.01 mg		Exact identifier — unii+route 63 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE	2165RE0K14	TABLET, FILM COATED / ORAL		40 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
COPOVIDONE	COPOVIDONE K25-31	D9C330MD8B	TABLET, FILM COATED / ORAL		5917 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE, DELAYED RELEASE / ORAL		5 mg	Exact identifier — unii+route 63 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	POWDER, FOR SUSPENSION / ORAL	0.01 mg		Exact identifier — unii+route 63 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SOLUTION / ORAL	50 mg/5ml		Exact identifier — unii+route 63 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	TABLET / ORAL		495 mg	Exact identifier — unii+route 63 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SUSPENSION / ORAL		10 mg	Exact identifier — unii+route 63 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	POWDER, FOR SUSPENSION / ORAL	0.01 mg		Exact identifier — unii+route 63 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	TABLET / ORAL		495 mg	Exact identifier — unii+route 63 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078926-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2011-02-11
A078926-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2011-02-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A078926-001	AB1
A078926-002	AB1

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-02-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-02-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-02-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-02-11	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A078926-001	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078926-002	AB1	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078926-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078926-002	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078926-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078926-002	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078926-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078926-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078926-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078926-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078926-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078926-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078926-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078926-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078926-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078926-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078926-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078926-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078926-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078926-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078926-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078926-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078926-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078926-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078926-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078926-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078926-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078926-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078926-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078926-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078926-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078926-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078926-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078926-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078926-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078926-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078926-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078926-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078926-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078926-002	AB	1	`4b0b4de00fa7…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Zydus Lifesciences Limited	b033c169-4943-4ad9-ace0-7e4a1f0dc100	2024-11-30		Exact identifier ndc (package): 65841-706-77 ndc (package): 65841-706-01 ndc (package): 65841-705-10 ndc (package): 65841-705-01 ndc (package): 65841-706-10 ndc (package): 65841-706-05 ndc (package): 65841-705-05 ndc (product): 65841-705 ndc (product): 65841-706 ndc11 (package): 65841070601 ndc11 (package): 65841070501 ndc11 (package): 65841070610 ndc11 (package): 65841070605 ndc11 (package): 65841070505 ndc11 (package): 65841070677 ndc11 (package): 65841070510 spl id: e9f9a5e6-0454-4601-90e4-b170bb325eb6 spl set id: b033c169-4943-4ad9-ace0-7e4a1f0dc100

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.