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 02:31:09

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
0409-4031-01	ML - Milliliter	0409-4031	b51ff002-9034-4202-9bc3-f067cd7cd2a6	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0409-4031	0409-4031-01

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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N016269-001	MANNITOL 5%	MANNITOL	5GM/100ML	INJECTABLE / INJECTION		Approved before 1982
N016269-002	MANNITOL 10%	MANNITOL	10GM/100ML	INJECTABLE / INJECTION		Approved before 1982
N016269-003	MANNITOL 15%	MANNITOL	15GM/100ML	INJECTABLE / INJECTION		Approved before 1982
N016269-004	MANNITOL 20%	MANNITOL	20GM/100ML	INJECTABLE / INJECTION		Approved before 1982
N016269-005	MANNITOL 25%	MANNITOL	12.5GM/50ML	INJECTABLE / INJECTION		Approved before 1982
N016269-006	MANNITOL 25%	MANNITOL	12.5GM/50ML	INJECTABLE / INJECTION	AP		1994-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N016269-006	AP

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 7 · 264 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
2026-10-15 13:18:30	2026-09	N016269-001	MANNITOL 5%	5GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N016269-002	MANNITOL 10%	10GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N016269-003	MANNITOL 15%	15GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N016269-004	MANNITOL 20%	20GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N016269-005	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION		Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N016269-006	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION	AP		1994-08-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N016269-001	MANNITOL 5%	5GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016269-002	MANNITOL 10%	10GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016269-003	MANNITOL 15%	15GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016269-004	MANNITOL 20%	20GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016269-005	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION		Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016269-006	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION	AP		1994-08-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016269-001	MANNITOL 5%	5GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016269-002	MANNITOL 10%	10GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016269-003	MANNITOL 15%	15GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016269-004	MANNITOL 20%	20GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016269-005	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016269-006	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION	AP		1994-08-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016269-001	MANNITOL 5%	5GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016269-002	MANNITOL 10%	10GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016269-003	MANNITOL 15%	15GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016269-004	MANNITOL 20%	20GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016269-005	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016269-006	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION	AP		1994-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016269-001	MANNITOL 5%	5GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016269-002	MANNITOL 10%	10GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016269-003	MANNITOL 15%	15GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016269-004	MANNITOL 20%	20GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016269-005	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016269-006	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION	AP		1994-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016269-001	MANNITOL 5%	5GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016269-002	MANNITOL 10%	10GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016269-003	MANNITOL 15%	15GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016269-004	MANNITOL 20%	20GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016269-005	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016269-006	MANNITOL 25%	12.5GM/50ML	INJECTABLE / INJECTION	AP		1994-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016269-001	MANNITOL 5%	5GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016269-002	MANNITOL 10%	10GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016269-003	MANNITOL 15%	15GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016269-004	MANNITOL 20%	20GM/100ML	INJECTABLE / INJECTION		Approved before 1982		`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N016269-006	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N016269-006	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016269-006	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016269-006	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016269-006	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016269-006	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016269-006	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016269-006	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016269-006	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016269-006	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016269-006	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016269-006	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016269-006	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016269-006	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016269-006	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016269-006	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016269-006	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016269-006	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016269-006	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016269-006	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016269-006	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016269-006	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016269-006	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016269-006	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016269-006	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016269-006	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016269-006	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016269-006	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016269-006	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016269-006	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016269-006	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016269-006	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016269-006	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016269-006	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016269-006	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016269-006	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016269-006	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016269-006	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016269-006	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016269-006	AP	1	`3a93d1ddd44b…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mannitol	MANNITOL	Hospira, Inc.	8ad3145e-00e7-4412-b9a5-06f00f264f30	2026-04-21	Warnings, Adverse reactions	Exact identifier ndc (package): 0409-4031-01 ndc11 (package): 00409403101

Reported adverse events (FAERS/openFDA)#

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