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 03:01:17

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
0378-3350-99	EA - Each	0378-3350	f456227d-3837-43f3-97de-e8850737db58	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0378-3350	0378-3350-99

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	Approval date
A075182-001	ESTRADIOL	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24
A075182-002	ESTRADIOL	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26
A075182-003	ESTRADIOL	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26
A075182-004	ESTRADIOL	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20
A075182-005	ESTRADIOL	ESTRADIOL	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20
A075182-006	ESTRADIOL	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A075182-001	AB2
A075182-002	AB2
A075182-003	AB2
A075182-004	AB2
A075182-005	AB2
A075182-006	AB2

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	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A075182-001	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075182-002	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075182-003	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075182-004	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075182-005	ESTRADIOL	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075182-006	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075182-001	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075182-002	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075182-003	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075182-004	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075182-005	ESTRADIOL	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075182-006	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075182-001	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075182-002	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075182-003	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075182-004	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075182-005	ESTRADIOL	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075182-006	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075182-001	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075182-002	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075182-003	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075182-004	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075182-005	ESTRADIOL	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075182-006	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-001	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-002	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-003	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-004	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-005	ESTRADIOL	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-006	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075182-001	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075182-002	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075182-003	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075182-004	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075182-005	ESTRADIOL	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075182-006	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-001	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-002	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-003	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-004	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 7 of 7 · 264 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A075182-001	AB2	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A075182-002	AB2	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A075182-003	AB2	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A075182-004	AB2	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A075182-005	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A075182-006	AB2	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075182-001	AB2	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A075182-002	AB2	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A075182-003	AB2	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A075182-004	AB2	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A075182-005	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A075182-006	AB2	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075182-001	AB2	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075182-002	AB2	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075182-003	AB2	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075182-004	AB2	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075182-005	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075182-006	AB2	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075182-001	AB2	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075182-002	AB2	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075182-003	AB2	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075182-004	AB2	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075182-005	AB2	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075182-006	AB2	1	`a50c72e98297…`

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
Estradiol	ESTRADIOL	Mylan Pharmaceuticals Inc.	e7e6da3b-8485-1382-61c9-e9b369018b98	2025-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 0378-3350-99 ndc11 (package): 00378335099

Reported adverse events (FAERS/openFDA)#

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