GABAPENTIN

Manufacturer: Northwind Pharmaceuticals
Effective date: 2018-06-20
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 00:10:13

Label at a glance#

ProductGABAPENTIN

Active ingredientGABAPENTIN

Label structure3 sections

Contacts and useful links#

Websitewww.fda.gov

www.fda.gov/drugs/drugsafety/ucm085729

Label contents#

Full prescribing information#

HOW SUPPLIED

HOW SUPPLIED SECTION

300 mg Capsules (Yellow/Yellow colored, size '1' hard gelatin capsules with "104" printed on body of capsules containing white to off white granular powder) Bottles of 30, 60 and 90 Capsules.

MedGuide Section

SPL MEDGUIDE SECTION

medguide

300mg Gabapentin Capsule Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

51655-379-25

NDC: 51655-379-25

MFG: 49483-606-50

Gabapentin 300mg

60 Capsules

Rx Only

Lot #:

Exp.Date:

Each capsule contains:

Gabapentin,USP....300mg

Dosage: See prescriber's instructions.

Store between 59 to 86 degrees F.

Store in this tight, light-resistant container. Protect from moisture. Keep this out of the reach of children.

Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729

Mfg by: Marksans Pharma Ltd. Verna Indl. Estate, Verna, Goa-403 722, India

Distributed by: Time-Cap Labs, Inc. 7 Michael Ave. Farmingdale, NY 11735 Lot#

Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256

51655-379-52

NDC: 51655-379-52

MFG: 49483-606-50

Gabapentin 300mg

30 Capsules

Rx Only

Lot #:

Exp.Date:

Each capsule contains:

Gabapentin,USP....300mg

Dosage: See prescriber's instructions.

Store between 59 to 86 degrees F.

Store in this tight, light-resistant container. Protect from moisture. Keep this out of the reach of children.

Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729

Mfg by: Marksans Pharma Ltd. Verna Indl. Estate, Verna, Goa-403 722, India

Distributed by: Time-Cap Labs, Inc. 7 Michael Ave. Farmingdale, NY 11735 Lot#

Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256

51655-379-26

NDC: 51655-379-26

MFG: 49483-606-50

Gabapentin 300mg

90 Capsules

Rx Only

Lot #:

Exp.Date:

Each capsule contains:

Gabapentin,USP....300mg

Dosage: See prescriber's instructions.

Store between 59 to 86 degrees F.

Store in this tight, light-resistant container. Protect from moisture. Keep this out of the reach of children.

Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729

Mfg by: Marksans Pharma Ltd. Verna Indl. Estate, Verna, Goa-403 722, India

Distributed by: Time-Cap Labs, Inc. 7 Michael Ave. Farmingdale, NY 11735 Lot#

Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51655-379-25	2024-05-14	C162847	48780-1	ba0f9c33-13b3-a910-e053-dadaa90a0b85	92dade1a-f9ae-83c9-e053-2995a90ab833
51655-379-26	2024-05-14	C162847	48780-1	ba0f9c33-13b3-a910-e053-dadaa90a0b85	92dade1a-f9ae-83c9-e053-2995a90ab833
51655-379-52	2024-05-14	C162847	48780-1	ba0f9c33-13b3-a910-e053-dadaa90a0b85	92dade1a-f9ae-83c9-e053-2995a90ab833
51655-379-25	2021-01-29	C162847	48780-1	ba0f9c33-13b3-a910-e053-dadaa90a0b85	92dade1a-f9ae-83c9-e053-2995a90ab833
51655-379-26	2021-01-29	C162847	48780-1	ba0f9c33-13b3-a910-e053-dadaa90a0b85	92dade1a-f9ae-83c9-e053-2995a90ab833
51655-379-52	2021-01-29	C162847	48780-1	ba0f9c33-13b3-a910-e053-dadaa90a0b85	92dade1a-f9ae-83c9-e053-2995a90ab833

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51655-379-25	EA - Each	51655-379	1bba32a7-eea0-4ca9-9857-f0187e606b1b	1	2019-12-10
49483-606-01	EA - Each	49483-606	4e9edb99-1ad9-432a-a9c6-3fedef6c4fe0	1	2016-05-16
49483-606-10	EA - Each	49483-606	e4dbd10f-f71c-419f-806d-95db7517babb	1	2021-06-02
49483-606-50	EA - Each	49483-606	2d45f7da-94ff-4495-b091-90adf7deda6e	1	2016-05-16

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

GABAPENTIN
LACTOSE MONOHYDRATE
STARCH, CORN
TALC
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
PROPYLENE GLYCOL
SHELLAC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51655-379	51655-379-25, 51655-379-52, 51655-379-26
49483-606

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
STARCH, CORN	O8232NY3SJ	IACT
TALC	7SEV7J4R1U	IACT
GELATIN	2G86QN327L	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SHELLAC	46N107B71O	IACT
GABAPENTIN	6CW7F3G59X	ACTIB

Source Document#

Source XML

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 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090007-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21
A090007-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21
A090007-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A090007-001	AB
A090007-002	AB
A090007-003	AB

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 4 · 129 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
2026-09-14 22:38:34	2026-08	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090007-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090007-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090007-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090007-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090007-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090007-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090007-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090007-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090007-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090007-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090007-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090007-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090007-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090007-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090007-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090007-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090007-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090007-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090007-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090007-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090007-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090007-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090007-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090007-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090007-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090007-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090007-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090007-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090007-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090007-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090007-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090007-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090007-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090007-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090007-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090007-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090007-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090007-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090007-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090007-001	AB	1	`301d65b070ca…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	TIME CAP LABORATORIES, INC	08880902-bd44-41b6-866b-2cbad4c3f2b1	2026-07-30	Warnings, Adverse reactions	Exact identifier ndc (product): 49483-606
186b7c4c-d94e-5969-e063-6294a90aa856			92dade1a-f9ae-83c9-e053-2995a90ab833	2024-01-01		Exact identifier spl set id: 92dade1a-f9ae-83c9-e053-2995a90ab833

Reported adverse events (FAERS/openFDA)#

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