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 01:08:34

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
65483-391-10	EA - Each	65483-391	0d4cc7cb-62f7-4bce-ae42-d26335e7d1b3	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65483-391	65483-391-10

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 44.

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	RLD / RS	Approval date
N018716-001	TRANDATE	LABETALOL HYDROCHLORIDE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24
N018716-002	TRANDATE	LABETALOL HYDROCHLORIDE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01
N018716-003	TRANDATE	LABETALOL HYDROCHLORIDE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01
N018716-004	TRANDATE	LABETALOL HYDROCHLORIDE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01

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 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018716-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018716-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018716-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018716-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018716-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018716-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018716-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018716-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018716-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018716-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018716-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018716-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018716-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018716-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018716-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018716-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018716-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018716-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018716-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018716-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018716-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018716-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018716-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018716-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018716-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018716-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018716-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018716-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018716-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018716-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018716-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018716-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018716-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018716-003	AB	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018716-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018716-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018716-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018716-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018716-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018716-003	AB	1	`a67488948f0b…`

Reported adverse events (FAERS/openFDA)#

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