GABAPENTIN

Manufacturer: Aphena Pharma Solutions - Tennessee, LLC
Effective date: 2019-08-01
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 20:29:47

Label at a glance#

ProductGABAPENTIN

Active ingredientGABAPENTIN

Label structure6 sections

Label contents#

Full prescribing information#

HOW SUPPLIED

HOW SUPPLIED SECTION

100 mg Capsules (White/White colored, size '3' hard gelatin capsules with "103" printed on body of capsules containing white to off white granular powder) Bottles of 100 & 500

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 100 & 500

HOW SUPPLIED

HOW SUPPLIED SECTION

400 mg Capsules (Orange/Orange colored, size '0' hard gelatin capsules with "105" printed on body of capsules containing white to off white granular powder) Bottles of 100 & 500

SPL MEDGUIDE SECTION

gab medguide

Repackaging Information

SPL UNCLASSIFIED SECTION

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count	400 mg
90	71610-195-60
270	71610-195-92

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TN
Cookeville, TN 38506

20190801JH

PRINCIPAL DISPLAY PANEL - 400 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71610-195 - Gabapentin, USP 400 mg - Rx Only
Bottle Label 400 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310432	gabapentin 400 MG Oral Capsule	PSN	3
310432	gabapentin 400 MG Oral Capsule	SCD	3

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71610-195-60	2023-01-30	C162847	48780-1	f386c649-a566-0266-e053-dadaa90a7c1a	b552a38a-5ada-4e79-a5ed-c785dcf5b568
71610-195-92	2023-01-30	C162847	48780-1	f386c649-a566-0266-e053-dadaa90a7c1a	b552a38a-5ada-4e79-a5ed-c785dcf5b568

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71610-195-60	GABAPENTIN	90 in 1 BOTTLE	CAPSULE	90		3
71610-195-92	GABAPENTIN	270 in 1 BOTTLE	CAPSULE	270		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-195	GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3	Legacy NDC, 2 package rows	20190923_b552a38a-5ada-4e79-a5ed-c785dcf5b568.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-195-60	EA - Each	71610-195	b31c62d7-09b0-4d98-ae13-5ef19e9f2a21	1	2019-02-13
71610-195-92	EA - Each	71610-195	2bee30e1-aa69-4ce8-b4a6-ab0abc9047dd	1	2019-11-12
49483-607-01	EA - Each	49483-607	eb970281-cd52-4169-aca1-b9bd9a199b32	1	2016-05-16
49483-607-10	EA - Each	49483-607	9f6ecc9f-cc58-487c-8575-3e1c94a4072f	1	2021-06-02
49483-607-50	EA - Each	49483-607	f8a18fb2-a6fb-49c3-9f9b-6a71e4d1f42c	1	2016-05-16

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

GABAPENTIN
LACTOSE MONOHYDRATE
STARCH, CORN
TALC
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2
PROPYLENE GLYCOL
SHELLAC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71610-195	71610-195-60, 71610-195-92
49483-607

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
FD&C BLUE NO. 2	L06K8R7DQK	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): 49483-607
5918274e-e48f-4599-83dc-e782c98847f9			b552a38a-5ada-4e79-a5ed-c785dcf5b568	2019-08-01		Exact identifier spl id: 5918274e-e48f-4599-83dc-e782c98847f9 spl set id: b552a38a-5ada-4e79-a5ed-c785dcf5b568

Reported adverse events (FAERS/openFDA)#

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