GABAPENTIN

Product NDC: 70010-109
11-digit product format: 700100109
Labeler code: 70010
Product ID: 70010-109_44f3f3fb-7803-2bc9-e063-6394a90acefe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GABAPENTIN
Dosage form: CAPSULE
Route: ORAL
Labeler: Granules Pharmaceuticals Inc.
Application: ANDA075360
Marketing category: ANDA
Marketing start: 2020-09-07
Substance: GABAPENTIN
Active strength: 300 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075360-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06
A075360-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06
A075360-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075360-001	AB
A075360-002	AB
A075360-003	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 3 · 99 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
2024-11-08 22:44 UTC	2024-11	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC	2024-11	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC	2024-11	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`5aa47cf7b7d7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-11-08 22:44 UTC	2024-11	A075360-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC	2024-11	A075360-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC	2024-11	A075360-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075360-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075360-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075360-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075360-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075360-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075360-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075360-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075360-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075360-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075360-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075360-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075360-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075360-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075360-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075360-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075360-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075360-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075360-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075360-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075360-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075360-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075360-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075360-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075360-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075360-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075360-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075360-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075360-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075360-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075360-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075360-001	AB	1	`5aa47cf7b7d7…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	Granules Pharmaceuticals Inc	c681c804-c6f3-d63b-e053-2995a90a6b8f	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	397fd6d3-317b-4b61-a52b-3a09ca1d88a4	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	13640281-26b4-402e-8f69-7c81cd6e0376	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	ST. MARY'S MEDICAL PARK PHARMACY	3aaf3d6e-c6d5-89f5-e063-6394a90a9b77	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Granules Pharmaceuticals Inc.	b20ee34a-7f2d-4d62-a161-898565f74547	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360 ndc (product): 70010-109
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	c859e666-d510-426b-e053-2995a90a9a3c	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Asclemed USA, Inc.	5fb79774-c2d4-47ba-9a16-eb367d0fdcff	2023-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Proficient Rx LP	aa3ab216-372a-4a72-bfd1-88a1ffa31ba3	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Proficient Rx LP	185f264e-db32-41cd-b90d-519717b97850	2021-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360

Additional Listing Data#

Finished product: Yes
Brand name base: GABAPENTIN
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GABAPENTIN	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6CW7F3G59X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310430	Internal RxNorm lookup
310431	Internal RxNorm lookup
310432	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b20ee34a-7f2d-4d62-a161-898565f74547	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70010-109-01	GABAPENTIN	100 in 1 BOTTLE	CAPSULE	100	4
70010-109-05	GABAPENTIN	500 in 1 BOTTLE	CAPSULE	500	4
70010-109-10	GABAPENTIN	1000 in 1 BOTTLE	CAPSULE	1000	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70010-109-01	EA - Each	70010-109	1e4d7900-076f-4d6a-9352-e1349b021b61	1	2021-01-08
70010-109-05	EA - Each	70010-109	c28b0521-33dd-40dc-8c73-7a486a97e73b	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70010-109	GABAPENTIN CAPSULE [GRANULES PHARMACEUTICALS INC.]	3	Current NDC, Legacy NDC, 3 package rows	20230217_b20ee34a-7f2d-4d62-a161-898565f74547.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
310431	gabapentin 300 MG Oral Capsule	PSN	13640281-26b4-402e-8f69-7c81cd6e0376	104
310431	gabapentin 300 MG Oral Capsule	PSN	397fd6d3-317b-4b61-a52b-3a09ca1d88a4	104
310431	gabapentin 300 MG Oral Capsule	SCD	13640281-26b4-402e-8f69-7c81cd6e0376	104
310431	gabapentin 300 MG Oral Capsule	SCD	397fd6d3-317b-4b61-a52b-3a09ca1d88a4	104
310430	gabapentin 100 MG Oral Capsule	PSN	b20ee34a-7f2d-4d62-a161-898565f74547	4
310431	gabapentin 300 MG Oral Capsule	PSN	b20ee34a-7f2d-4d62-a161-898565f74547	4
310432	gabapentin 400 MG Oral Capsule	PSN	b20ee34a-7f2d-4d62-a161-898565f74547	4
310430	gabapentin 100 MG Oral Capsule	SCD	b20ee34a-7f2d-4d62-a161-898565f74547	4
310431	gabapentin 300 MG Oral Capsule	SCD	b20ee34a-7f2d-4d62-a161-898565f74547	4
310432	gabapentin 400 MG Oral Capsule	SCD	b20ee34a-7f2d-4d62-a161-898565f74547	4
310431	gabapentin 300 MG Oral Capsule	PSN	5fb79774-c2d4-47ba-9a16-eb367d0fdcff	1
310431	gabapentin 300 MG Oral Capsule	SCD	5fb79774-c2d4-47ba-9a16-eb367d0fdcff	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70010-109-01	70010010901	100 CAPSULE in 1 BOTTLE (70010-109-01)	100 capsule	2020-09-07	0000-00-00	No	No	Current
70010-109-05	70010010905	500 CAPSULE in 1 BOTTLE (70010-109-05)	500 capsule	2020-09-07	0000-00-00	No	No	Current
70010-109-10	70010010910	1000 CAPSULE in 1 BOTTLE (70010-109-10)	1000 capsule	2020-09-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GABAPENTIN	Bryant Ranch Prepack	2026-05-22	HUMAN PRESCRIPTION DRUG LABEL	104
GABAPENTIN	Bryant Ranch Prepack	2026-05-22	HUMAN PRESCRIPTION DRUG LABEL	104
GABAPENTIN	Granules Pharmaceuticals Inc. \| Granules India Limited	2025-12-02	HUMAN PRESCRIPTION DRUG LABEL	4
GABAPENTIN	REMEDYREPACK INC.	2024-03-29	HUMAN PRESCRIPTION DRUG LABEL	2
GABAPENTIN	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-09-30	HUMAN PRESCRIPTION DRUG LABEL	1