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 01:08:57

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
0088-2220-33	ML - Milliliter	0088-2220	0def01d8-523e-42f3-8e2e-19e1d71bb8c7	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0088-2220	0088-2220-33

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
021081	Lantus	insulin glargine	351(a)	Rx	2026-09-01

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.

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	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021081-001	LANTUS	100 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2000-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	LANTUS SOLOSTAR	300 UNITS/3ML (100 UNITS/ML)	INJECTABLE / INJECTION	RLD, RS	2007-04-27	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021081-001	LANTUS	100 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2000-04-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	LANTUS SOLOSTAR	300 UNITS/3ML (100 UNITS/ML)	INJECTABLE / INJECTION	RLD, RS	2007-04-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021081-001	LANTUS	100 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2000-04-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021081-002	LANTUS SOLOSTAR	300 UNITS/3ML (100 UNITS/ML)	INJECTABLE / INJECTION	RLD, RS	2007-04-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021081-001	LANTUS	100 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2000-04-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021081-002	LANTUS SOLOSTAR	300 UNITS/3ML (100 UNITS/ML)	INJECTABLE / INJECTION	RLD, RS	2007-04-27	`ea99ee380514…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021081-001	7713930	2023-06-13		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-001	7476652	2023-07-23		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-001	7713930*PED	2023-12-13		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-001	7476652*PED	2024-01-23		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-001	7918833	2027-09-23		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-001	7918833*PED	2028-03-23		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	8603044	2024-03-02		Drug product	2014-01-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9233211	2024-03-02		Drug product	2016-01-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9408979	2024-03-02		Drug product	2016-09-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9526844	2024-03-02		Drug product	2016-12-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9604008	2024-03-02		Drug product	2017-03-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9610409	2024-03-02		Drug product	2017-04-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9775954	2024-03-02		Drug product	2017-10-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9827379	2024-03-02	U-2146	Drug product	2017-11-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	8556864	2024-03-03		Drug product	2013-11-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9011391	2024-03-26	U-1832		2015-05-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	8992486	2024-06-05		Drug product	2015-04-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9604009	2024-08-16		Drug product	2017-03-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9533105	2024-08-17		Drug product	2017-01-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9623189	2024-08-19		Drug product	2017-04-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9561331	2024-08-28		Drug product	2017-02-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	8512297	2024-09-15		Drug product	2013-08-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	8679069	2025-04-12		Drug product	2014-03-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9717852	2033-04-08		Drug product	2018-07-11	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021081-001	7713930	2023-06-13		Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-001	7476652	2023-07-23		Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-001	7713930*PED	2023-12-13		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-001	7476652*PED	2024-01-23		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-001	7918833	2027-09-23		Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-001	7918833*PED	2028-03-23		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	8603044	2024-03-02		Drug product	2014-01-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	9233211	2024-03-02		Drug product	2016-01-13	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	9408979	2024-03-02		Drug product	2016-09-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	9526844	2024-03-02		Drug product	2016-12-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	9604008	2024-03-02		Drug product	2017-03-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	9610409	2024-03-02		Drug product	2017-04-04	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	9775954	2024-03-02		Drug product	2017-10-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	9827379	2024-03-02	U-2146	Drug product	2017-11-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	8556864	2024-03-03		Drug product	2013-11-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	9011391	2024-03-26	U-1832		2015-05-01	`3f01610625f2…`

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
Lantus Solostar	INSULIN GLARGINE	sanofi-aventis U.S. LLC	d5e07a0c-7e14-4756-9152-9fea485d654a	2025-06-02	Warnings, Adverse reactions	Exact identifier ndc (package): 0088-2220-33 ndc11 (package): 00088222033

Reported adverse events (FAERS/openFDA)#

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