Gabapentin

Product NDC: 50228-180
11-digit product format: 502280180
Labeler code: 50228
Product ID: 50228-180_156a9379-da89-427a-9135-b14af9f8787f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: ScieGen Pharmaceuticals, Inc.
Application: ANDA204989
Marketing category: ANDA
Marketing start: 2016-02-18
Substance: GABAPENTIN
Active strength: 300 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204989-001	RELGAABI	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18
A204989-002	RELGAABI	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18
A204989-003	RELGAABI	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18
A204989-004	RELGAABI	GABAPENTIN	200MG	CAPSULE / ORAL	AB	2026-03-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A204989-001	AB
A204989-002	AB
A204989-003	AB
A204989-004	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A204989-001	RELGAABI	100MG	CAPSULE / ORAL	AB	2016-02-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204989-002	RELGAABI	300MG	CAPSULE / ORAL	AB	2016-02-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204989-003	RELGAABI	400MG	CAPSULE / ORAL	AB	2016-02-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204989-004	RELGAABI	200MG	CAPSULE / ORAL	AB	2026-03-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A204989-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204989-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204989-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204989-004	AB	1	`a50c72e98297…`

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 3 · 53 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	ScieGen Pharmaceuticals, Inc.	16542ee6-0e0e-4d3c-8b32-60ff6ef48846	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989 ndc (product): 50228-180
Gabapentin	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	4a95f18e-0de4-4ce1-9f97-bc2e8a5bac6a	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	HAWAII REPACK, INC.	dd7adad2-e2f5-4b43-90a4-522bce0be5b3	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Northwind Health Company, LLC	1b44a3ab-4d06-205f-e063-6294a90af368	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Asclemed USA, Inc.	9a829dc3-b2d8-4d19-a579-0597217cec9b	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	b7a29b99-ce23-950e-e053-2995a90a1934	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	4c49d34d-bb47-406b-8f2d-b4834b2ee9d0	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Coupler LLC	5385e27c-f2fa-32d5-e063-6294a90a0a8c	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Direct_Rx	f8998c1c-c359-6f01-e053-6294a90aebf4	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	b8b7e045-a7fe-8539-e053-2a95a90a40f8	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals Inc.	100ff86c-56a8-4770-9db3-b9bc6b1bd2f7	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals Inc.	e3429322-c442-4146-bb68-bcc3a8d01552	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals Inc.	2625c0ef-5295-41de-9e81-88001a6cbecc	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals, Inc.	41dcc917-68d1-49f0-8223-44c21ca259ef	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Coupler LLC	5073abda-321f-29d1-e063-6394a90a59ac	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	PHOENIX RX LLC	4f95c01f-200e-bfd7-e063-6394a90abc38	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	48037fc4-1aab-4ae8-aede-7c55b494877a	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	cb81fd89-b32b-4538-bf5c-ab02f65b3458	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	2ac0622c-440a-49a0-974f-726e6ac72a0e	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	691205ba-fa65-4bc9-ba20-7d361382cff9	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989

Additional Listing Data#

Finished product: Yes
Brand name base: Gabapentin
Listing expiration: 2027-12-31

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
16542ee6-0e0e-4d3c-8b32-60ff6ef48846	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
50228-180-01	Gabapentin	100 in 1 BOTTLE, PLASTIC	CAPSULE	100	15
50228-180-05	Gabapentin	500 in 1 BOTTLE, PLASTIC	CAPSULE	500	15
50228-180-10	Gabapentin	1000 in 1 BOTTLE, PLASTIC	CAPSULE	1000	15
50228-180-30	Gabapentin	30 in 1 BOTTLE, PLASTIC	CAPSULE	30	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50228-180-01	EA - Each	50228-180	efab403a-1ba3-49c1-9ad8-af4ebc29ec56	1	2019-01-24
50228-180-05	EA - Each	50228-180	c6d1aa1a-856c-48e5-b136-6eb5d65b68ce	1	2018-09-05
50228-180-10	EA - Each	50228-180	83116bd9-dc81-414b-aded-c4ac43675f7e	1	2021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50228-180	GABAPENTIN CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]	13	Current NDC, Legacy NDC, 4 package rows	20231109_16542ee6-0e0e-4d3c-8b32-60ff6ef48846.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	691205ba-fa65-4bc9-ba20-7d361382cff9	105
310431	gabapentin 300 MG Oral Capsule	PSN	2ac0622c-440a-49a0-974f-726e6ac72a0e	105
310431	gabapentin 300 MG Oral Capsule	SCD	691205ba-fa65-4bc9-ba20-7d361382cff9	105
310431	gabapentin 300 MG Oral Capsule	SCD	2ac0622c-440a-49a0-974f-726e6ac72a0e	105
310431	gabapentin 300 MG Oral Capsule	PSN	1af098ad-28b5-463f-8efa-24d70a77d64c	101
310431	gabapentin 300 MG Oral Capsule	SCD	1af098ad-28b5-463f-8efa-24d70a77d64c	101
310430	gabapentin 100 MG Oral Capsule	PSN	16542ee6-0e0e-4d3c-8b32-60ff6ef48846	15
310431	gabapentin 300 MG Oral Capsule	PSN	16542ee6-0e0e-4d3c-8b32-60ff6ef48846	15
310432	gabapentin 400 MG Oral Capsule	PSN	16542ee6-0e0e-4d3c-8b32-60ff6ef48846	15
310430	gabapentin 100 MG Oral Capsule	SCD	16542ee6-0e0e-4d3c-8b32-60ff6ef48846	15
310431	gabapentin 300 MG Oral Capsule	SCD	16542ee6-0e0e-4d3c-8b32-60ff6ef48846	15
310432	gabapentin 400 MG Oral Capsule	SCD	16542ee6-0e0e-4d3c-8b32-60ff6ef48846	15
310430	gabapentin 100 MG Oral Capsule	PSN	76f5eff8-698f-2753-e053-2991aa0ae7f9	12
310431	gabapentin 300 MG Oral Capsule	PSN	76f5eff8-698f-2753-e053-2991aa0ae7f9	12
310432	gabapentin 400 MG Oral Capsule	PSN	76f5eff8-698f-2753-e053-2991aa0ae7f9	12
310430	gabapentin 100 MG Oral Capsule	SCD	76f5eff8-698f-2753-e053-2991aa0ae7f9	12
310431	gabapentin 300 MG Oral Capsule	SCD	76f5eff8-698f-2753-e053-2991aa0ae7f9	12
310432	gabapentin 400 MG Oral Capsule	SCD	76f5eff8-698f-2753-e053-2991aa0ae7f9	12
310431	gabapentin 300 MG Oral Capsule	PSN	e877a425-2b7f-4e43-a1f9-24019cbf9685	10
310431	gabapentin 300 MG Oral Capsule	SCD	e877a425-2b7f-4e43-a1f9-24019cbf9685	10
310430	gabapentin 100 MG Oral Capsule	PSN	ed3a0d48-2e98-44ee-8743-880d1221a480	6
310431	gabapentin 300 MG Oral Capsule	PSN	ed3a0d48-2e98-44ee-8743-880d1221a480	6
310430	gabapentin 100 MG Oral Capsule	SCD	ed3a0d48-2e98-44ee-8743-880d1221a480	6
310431	gabapentin 300 MG Oral Capsule	SCD	ed3a0d48-2e98-44ee-8743-880d1221a480	6
310431	gabapentin 300 MG Oral Capsule	PSN	ed9cb5fe-7a2e-e0bc-e053-2a95a90a4470	4
310431	gabapentin 300 MG Oral Capsule	PSN	a36ffbd9-a6d0-120a-e053-2995a90a9eac	4
310431	gabapentin 300 MG Oral Capsule	PSN	b56ce49e-7c73-2cc9-e053-2995a90a4ab8	4
310431	gabapentin 300 MG Oral Capsule	PSN	bff3beea-1f05-4e84-bcd2-d05782acddae	4
310431	gabapentin 300 MG Oral Capsule	PSN	d294f6aa-ed82-90a2-e053-2995a90a2896	4
310431	gabapentin 300 MG Oral Capsule	SCD	a36ffbd9-a6d0-120a-e053-2995a90a9eac	4
310431	gabapentin 300 MG Oral Capsule	SCD	b56ce49e-7c73-2cc9-e053-2995a90a4ab8	4
310431	gabapentin 300 MG Oral Capsule	SCD	bff3beea-1f05-4e84-bcd2-d05782acddae	4
310431	gabapentin 300 MG Oral Capsule	SCD	d294f6aa-ed82-90a2-e053-2995a90a2896	4
310431	gabapentin 300 MG Oral Capsule	SCD	ed9cb5fe-7a2e-e0bc-e053-2a95a90a4470	4
310430	gabapentin 100 MG Oral Capsule	PSN	9a829dc3-b2d8-4d19-a579-0597217cec9b	3
310431	gabapentin 300 MG Oral Capsule	PSN	9a829dc3-b2d8-4d19-a579-0597217cec9b	3
310431	gabapentin 300 MG Oral Capsule	PSN	54c09aa5-6724-480a-a115-c88484e39e93	3
310431	gabapentin 300 MG Oral Capsule	PSN	25befbfa-5125-4363-8306-f862e81c0a6f	3
310431	gabapentin 300 MG Oral Capsule	PSN	41dcc917-68d1-49f0-8223-44c21ca259ef	3
310432	gabapentin 400 MG Oral Capsule	PSN	9a829dc3-b2d8-4d19-a579-0597217cec9b	3
310430	gabapentin 100 MG Oral Capsule	SCD	9a829dc3-b2d8-4d19-a579-0597217cec9b	3
310431	gabapentin 300 MG Oral Capsule	SCD	41dcc917-68d1-49f0-8223-44c21ca259ef	3
310431	gabapentin 300 MG Oral Capsule	SCD	25befbfa-5125-4363-8306-f862e81c0a6f	3
310431	gabapentin 300 MG Oral Capsule	SCD	9a829dc3-b2d8-4d19-a579-0597217cec9b	3
310431	gabapentin 300 MG Oral Capsule	SCD	54c09aa5-6724-480a-a115-c88484e39e93	3
310432	gabapentin 400 MG Oral Capsule	SCD	9a829dc3-b2d8-4d19-a579-0597217cec9b	3
310431	gabapentin 300 MG Oral Capsule	PSN	1749d731-bc8c-4374-b2a9-7c809c457f56	2
310431	gabapentin 300 MG Oral Capsule	PSN	b7a29b99-ce23-950e-e053-2995a90a1934	2
310431	gabapentin 300 MG Oral Capsule	PSN	bd5c9279-a1e3-2a59-e053-2a95a90a33a2	2
310431	gabapentin 300 MG Oral Capsule	PSN	1b44a3ab-4d06-205f-e063-6294a90af368	2
310431	gabapentin 300 MG Oral Capsule	SCD	b7a29b99-ce23-950e-e053-2995a90a1934	2
310431	gabapentin 300 MG Oral Capsule	SCD	1749d731-bc8c-4374-b2a9-7c809c457f56	2
310431	gabapentin 300 MG Oral Capsule	SCD	1b44a3ab-4d06-205f-e063-6294a90af368	2
310431	gabapentin 300 MG Oral Capsule	SCD	bd5c9279-a1e3-2a59-e053-2a95a90a33a2	2
310431	gabapentin 300 MG Oral Capsule	PSN	c300bb3e-a556-4094-9114-6f9ecff2d77c	1
310431	gabapentin 300 MG Oral Capsule	PSN	1b73e9db-eddb-49ba-9778-01d39ece4d16	1
310431	gabapentin 300 MG Oral Capsule	PSN	4f95c01f-200e-bfd7-e063-6394a90abc38	1
310431	gabapentin 300 MG Oral Capsule	PSN	12f0c2ee-9a44-9778-e063-6294a90a3b58	1
310431	gabapentin 300 MG Oral Capsule	SCD	1b73e9db-eddb-49ba-9778-01d39ece4d16	1
310431	gabapentin 300 MG Oral Capsule	SCD	c300bb3e-a556-4094-9114-6f9ecff2d77c	1
310431	gabapentin 300 MG Oral Capsule	SCD	4f95c01f-200e-bfd7-e063-6394a90abc38	1
310431	gabapentin 300 MG Oral Capsule	SCD	12f0c2ee-9a44-9778-e063-6294a90a3b58	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50228-180-01	50228018001	100 CAPSULE in 1 BOTTLE, PLASTIC (50228-180-01)	100 capsule	2018-08-20	0000-00-00	No	No	Current
50228-180-05	50228018005	500 CAPSULE in 1 BOTTLE, PLASTIC (50228-180-05)	500 capsule	2016-02-18	0000-00-00	No	No	Current
50228-180-10	50228018010	1000 CAPSULE in 1 BOTTLE, PLASTIC (50228-180-10)	1000 capsule	2019-11-14	0000-00-00	No	No	Current
50228-180-30	50228018030	30 CAPSULE in 1 BOTTLE, PLASTIC (50228-180-30)	30 capsule	2016-02-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	ScieGen Pharmaceuticals, Inc. \| ScieGen Pharmaceuticals India Private Limited	2026-07-21	HUMAN PRESCRIPTION DRUG LABEL	16
Gabapentin	HAWAII REPACK, INC.	2026-07-02	HUMAN PRESCRIPTION DRUG LABEL	1
Gabapentin	Northwind Health Company, LLC	2026-06-22	HUMAN PRESCRIPTION DRUG LABEL	3
Gabapentin	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-06-17	HUMAN PRESCRIPTION DRUG LABEL	4
Gabapentin	St. Mary's Medical Park Pharmacy	2026-06-09	HUMAN PRESCRIPTION DRUG LABEL	3
Gabapentin	Coupler LLC	2026-06-05	HUMAN PRESCRIPTION DRUG LABEL	1
Gabapentin	Golden State Medical Supply, Inc.	2026-05-14	HUMAN PRESCRIPTION DRUG LABEL	12
Gabapentin	Preferred Pharmaceuticals, Inc.	2026-04-29	HUMAN PRESCRIPTION DRUG LABEL	3
Gabapentin	PHOENIX RX LLC	2026-04-16	HUMAN PRESCRIPTION DRUG LABEL	1
Gabapentin	Bryant Ranch Prepack	2026-04-09	HUMAN PRESCRIPTION DRUG LABEL	105
Gabapentin	Bryant Ranch Prepack	2026-04-09	HUMAN PRESCRIPTION DRUG LABEL	105
Gabapentin	Bryant Ranch Prepack	2026-03-31	HUMAN PRESCRIPTION DRUG LABEL	101
Gabapentin	REMEDYREPACK INC.	2026-03-31	HUMAN PRESCRIPTION DRUG LABEL	10
Gabapentin	A-S Medication Solutions	2026-02-24	HUMAN PRESCRIPTION DRUG LABEL	3
Gabapentin	Preferred Pharmaceuticals, Inc.	2026-01-14	HUMAN PRESCRIPTION DRUG LABEL	4
Gabapentin	A-S Medication Solutions	2025-10-28	HUMAN PRESCRIPTION DRUG LABEL	3
Gabapentin	Direct_Rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	4
Gabapentin	NuCare Pharmaceuticals,Inc.	2025-01-14	HUMAN PRESCRIPTION DRUG LABEL	2