GABAPENTIN

Product NDC: 72189-158
Requested package NDC: 72189-158-60
11-digit product format: 721890158
Labeler code: 72189
Product ID: 72189-158_2becf606-de3d-b686-e063-6294a90afe58
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GABAPENTIN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DIRECT RX
Application: ANDA203244
Marketing category: ANDA
Marketing start: 2020-12-01
Substance: GABAPENTIN
Active strength: 800 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203244-001	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2013-07-12
A203244-002	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2013-07-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203244-001	AB1
A203244-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A203244-001	GABAPENTIN	800MG	TABLET / ORAL	AB1		2013-07-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203244-002	GABAPENTIN	600MG	TABLET / ORAL	AB1		2013-07-12	`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	A203244-001	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203244-002	AB1	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 1 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	07c8bb17-9bd4-4fab-994d-0412205b53b4	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	b6db5ce9-bd4b-420d-88a7-df9d46144c81	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Strides Pharma Science Limited	bec31452-b52b-4698-ba4c-0b614780ee84	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	7d3fc163-25f0-2c61-e053-2991aa0a76e9	2025-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
GABAPENTIN	GABAPENTIN	DIRECT RX	a7e45e3f-e382-32ba-e053-2a95a90a2537	2025-01-17		Exact identifier application applno (ANDA): 203244 application number: ANDA203244 ndc (package): 72189-158-60 ndc (product): 72189-158 ndc11 (package): 72189015860
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	6e6b9d8f-9f9e-4760-96ea-fb8b0a3bbbdb	2024-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	47f2a06f-4eac-4dca-aa2a-a36dd4daaea0	2024-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	b4954172-5439-48fd-8348-8a2e0d2fee62	2024-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	c9944562-563a-423d-972c-f0313375d234	2024-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	56967a93-b3c0-4043-9241-585fc64e2624	2023-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	0eb27e64-1488-4083-82c7-cebb8c0605de	2023-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	ACI Healthcare USA, Inc.	d7646d5e-ca25-4ec5-9e4b-931edcb15a0e	2023-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	39149f0e-30ed-4671-8be7-2a484f65d63b	2020-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Proficient Rx LP	8b2f38ef-0a0c-45cc-88ca-cc086bf80641	2020-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	ba2a8352-5776-4edb-914e-ce1d18ccda32	2020-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244
Gabapentin	GABAPENTIN	Proficient Rx LP	c09c66fd-cb31-41dd-b00b-acc58bd809f7	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203244 application number: ANDA203244

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GABAPENTIN	800 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
310432	Internal RxNorm lookup
310434	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
a7e45e3f-e382-32ba-e053-2a95a90a2537	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
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
72189-158-30	GABAPENTIN	30 in 1 BOTTLE	TABLET, FILM COATED	30	15
72189-158-60	GABAPENTIN	60 in 1 BOTTLE	TABLET, FILM COATED	60	15
72189-158-72	GABAPENTIN	120 in 1 BOTTLE	TABLET, FILM COATED	120	15
72189-158-90	GABAPENTIN	90 in 1 BOTTLE	TABLET, FILM COATED	90	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-158-30	EA - Each	72189-158	0c8067f0-b4f7-4b75-a168-5f6c575a7f6e	1	2022-10-06
72189-158-60	EA - Each	72189-158	3d69bfae-5d0b-4243-a261-1bc935d08842	1	2022-10-06
72189-158-72	EA - Each	72189-158	1b652756-0879-4119-a30d-128978686ffe	1	2021-02-05
72189-158-90	EA - Each	72189-158	741ece5b-faac-45f5-bdf5-1ef4441b99df	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-158	GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN TABLET [DIRECT RX]	15	Current NDC, Legacy NDC, 4 package rows	20250119_a7e45e3f-e382-32ba-e053-2a95a90a2537.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
310430	gabapentin 100 MG Oral Capsule	PSN	a7e45e3f-e382-32ba-e053-2a95a90a2537	15
310432	gabapentin 400 MG Oral Capsule	PSN	a7e45e3f-e382-32ba-e053-2a95a90a2537	15
310434	gabapentin 800 MG Oral Tablet	PSN	a7e45e3f-e382-32ba-e053-2a95a90a2537	15
310430	gabapentin 100 MG Oral Capsule	SCD	a7e45e3f-e382-32ba-e053-2a95a90a2537	15
310432	gabapentin 400 MG Oral Capsule	SCD	a7e45e3f-e382-32ba-e053-2a95a90a2537	15
310434	gabapentin 800 MG Oral Tablet	SCD	a7e45e3f-e382-32ba-e053-2a95a90a2537	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-158-60	72189015860	60 TABLET, FILM COATED in 1 BOTTLE (72189-158-60)	2020-12-01	0000-00-00	No	No	Current