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 02:36:24

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
50419-491-04	EA - Each	50419-491	c130464b-016b-40c7-8a63-69cebbb5ee5a	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50419-491	50419-491-04

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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021258-001	CLIMARA PRO	ESTRADIOL; LEVONORGESTREL	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		RLD, RS	2003-11-21

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`f41ea6bd6efb…`

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
Climara Pro	ESTRADIOL AND LEVONORGESTREL	Bayer HealthCare Pharmaceuticals Inc.	184d3092-7fc6-4375-816b-1ab06bb99cfd	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 50419-491-04 ndc11 (package): 50419049104

Reported adverse events (FAERS/openFDA)#

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