Gabapentin

Product NDC: 69434-044
Requested package NDC: 69434-044-03
11-digit product format: 694340044
Labeler code: 69434
Product ID: 69434-044_457c0aa0-f1e5-d420-e063-6294a90a6d40
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Zhejiang Yongtai Pharmaceutical Co., Ltd
Application: ANDA213603
Marketing category: ANDA
Marketing start: 2025-12-03
Substance: GABAPENTIN
Active strength: 400 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A213603-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17
A213603-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17
A213603-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213603-001	AB
A213603-002	AB
A213603-003	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 · 117 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	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 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	A213603-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213603-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213603-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213603-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213603-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213603-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213603-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213603-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213603-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213603-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213603-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213603-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213603-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213603-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213603-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213603-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213603-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213603-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213603-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213603-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213603-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213603-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213603-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213603-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213603-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213603-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213603-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213603-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213603-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213603-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213603-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213603-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213603-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213603-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213603-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213603-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213603-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213603-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213603-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213603-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GABAPENTIN	400 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
f1eda6cc-d9b2-4df4-a09b-20eebded760f	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
69434-044-03	2024-12-12	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
69434-044-03	2024-12-12	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
69434-044-04	2024-12-12	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
69434-044-04	2024-12-12	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
69434-044-03	2023-01-30	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
69434-044-03	2023-01-30	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
69434-044-04	2023-01-30	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
69434-044-04	2023-01-30	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69434-044-03	Gabapentin	500 in 1 BOTTLE	CAPSULE	500		14
69434-044-04	Gabapentin	100 in 1 BOTTLE	CAPSULE	100		14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69434-044	GABAPENTIN CAPSULE [ZHEJIANG YONGTAI PHARMACEUTICAL CO., LTD]	12	Current NDC, Legacy NDC, 2 package rows	20250216_f1eda6cc-d9b2-4df4-a09b-20eebded760f.zip

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Zhejiang Yongtai Pharmaceutical Co., Ltd	f1eda6cc-d9b2-4df4-a09b-20eebded760f	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213603 application number: ANDA213603 ndc (package): 69434-044-03 ndc (product): 69434-044 ndc11 (package): 69434004403
Gabapentin	GABAPENTIN	Direct_Rx	e90d2e3d-ec86-7d1d-e053-2995a90a9167	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213603 application number: ANDA213603
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	2dad630a-09d8-4f40-bdad-24e877a9ee38	2024-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213603 application number: ANDA213603
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	ffe5321d-3405-46d5-a75f-c51e8f8d87b1	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213603 application number: ANDA213603

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	f1eda6cc-d9b2-4df4-a09b-20eebded760f	14
310431	gabapentin 300 MG Oral Capsule	PSN	f1eda6cc-d9b2-4df4-a09b-20eebded760f	14
310432	gabapentin 400 MG Oral Capsule	PSN	f1eda6cc-d9b2-4df4-a09b-20eebded760f	14
310430	gabapentin 100 MG Oral Capsule	SCD	f1eda6cc-d9b2-4df4-a09b-20eebded760f	14
310431	gabapentin 300 MG Oral Capsule	SCD	f1eda6cc-d9b2-4df4-a09b-20eebded760f	14
310432	gabapentin 400 MG Oral Capsule	SCD	f1eda6cc-d9b2-4df4-a09b-20eebded760f	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69434-044-03	69434004403	500 CAPSULE in 1 BOTTLE (69434-044-03)	500 capsule	2025-12-03	0000-00-00	No	No	Current