National Council for Prescription Drug Programs indexing - billing unit

Manufacturer: National Council for Prescription Drug Programs
Effective date: 2012-07-24
Label type: Indexing - Billing Unit
Version: 1
Source: full-release
Hydrated at: 2026-06-05 01:07:40

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63459-404-30	EA - Each	63459-404	0b92a604-7cc7-4d7f-9496-83e06eacf8a5	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63459-404	63459-404-30

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 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020646-001	GABITRIL	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	RLD, RS	1997-09-30
N020646-002	GABITRIL	TIAGABINE HYDROCHLORIDE	12MG	TABLET / ORAL	AB	RLD	1997-09-30
N020646-003	GABITRIL	TIAGABINE HYDROCHLORIDE	16MG	TABLET / ORAL	AB	RLD	1997-09-30
N020646-004	GABITRIL	TIAGABINE HYDROCHLORIDE	20MG	TABLET / ORAL			1997-09-30
N020646-005	GABITRIL	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	RLD	1999-04-16
N020646-006	GABITRIL	TIAGABINE HYDROCHLORIDE	6MG	TABLET / ORAL			2005-11-29
N020646-007	GABITRIL	TIAGABINE HYDROCHLORIDE	8MG	TABLET / ORAL			2005-11-29
N020646-008	GABITRIL	TIAGABINE HYDROCHLORIDE	10MG	TABLET / ORAL			2005-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020646-001	AB
N020646-002	AB
N020646-003	AB
N020646-005	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 9 · 344 observed 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
2026-09-14 22:38:34	2026-08	N020646-001	GABITRIL	4MG	TABLET / ORAL	AB	RLD, RS	1997-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020646-002	GABITRIL	12MG	TABLET / ORAL	AB	RLD	1997-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020646-003	GABITRIL	16MG	TABLET / ORAL	AB	RLD	1997-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020646-004	GABITRIL	20MG	TABLET / ORAL			1997-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020646-005	GABITRIL	2MG	TABLET / ORAL	AB	RLD	1999-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020646-006	GABITRIL	6MG	TABLET / ORAL			2005-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020646-007	GABITRIL	8MG	TABLET / ORAL			2005-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020646-008	GABITRIL	10MG	TABLET / ORAL			2005-11-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020646-001	GABITRIL	4MG	TABLET / ORAL	AB	RLD, RS	1997-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020646-002	GABITRIL	12MG	TABLET / ORAL	AB	RLD	1997-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020646-003	GABITRIL	16MG	TABLET / ORAL	AB	RLD	1997-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020646-004	GABITRIL	20MG	TABLET / ORAL			1997-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020646-005	GABITRIL	2MG	TABLET / ORAL	AB	RLD	1999-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020646-006	GABITRIL	6MG	TABLET / ORAL			2005-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020646-007	GABITRIL	8MG	TABLET / ORAL			2005-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020646-008	GABITRIL	10MG	TABLET / ORAL			2005-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020646-001	GABITRIL	4MG	TABLET / ORAL	AB	RLD, RS	1997-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-002	GABITRIL	12MG	TABLET / ORAL	AB	RLD	1997-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-003	GABITRIL	16MG	TABLET / ORAL	AB	RLD	1997-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-004	GABITRIL	20MG	TABLET / ORAL			1997-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-005	GABITRIL	2MG	TABLET / ORAL	AB	RLD	1999-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-006	GABITRIL	6MG	TABLET / ORAL			2005-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-007	GABITRIL	8MG	TABLET / ORAL			2005-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-008	GABITRIL	10MG	TABLET / ORAL			2005-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-001	GABITRIL	4MG	TABLET / ORAL	AB	RLD, RS	1997-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-002	GABITRIL	12MG	TABLET / ORAL	AB	RLD	1997-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-003	GABITRIL	16MG	TABLET / ORAL	AB	RLD	1997-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-004	GABITRIL	20MG	TABLET / ORAL			1997-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-005	GABITRIL	2MG	TABLET / ORAL	AB	RLD	1999-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-006	GABITRIL	6MG	TABLET / ORAL			2005-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-007	GABITRIL	8MG	TABLET / ORAL			2005-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-008	GABITRIL	10MG	TABLET / ORAL			2005-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020646-001	GABITRIL	4MG	TABLET / ORAL	AB	RLD, RS	1997-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-002	GABITRIL	12MG	TABLET / ORAL	AB	RLD	1997-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-003	GABITRIL	16MG	TABLET / ORAL	AB	RLD	1997-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-004	GABITRIL	20MG	TABLET / ORAL			1997-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-005	GABITRIL	2MG	TABLET / ORAL	AB	RLD	1999-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-006	GABITRIL	6MG	TABLET / ORAL			2005-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-007	GABITRIL	8MG	TABLET / ORAL			2005-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-008	GABITRIL	10MG	TABLET / ORAL			2005-11-29	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	N020646-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020646-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020646-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020646-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020646-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020646-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020646-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020646-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020646-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020646-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020646-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020646-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020646-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020646-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020646-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020646-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020646-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020646-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020646-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020646-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020646-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020646-005	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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