Gallifrey

Product NDC: 70700-326
11-digit product format: 707000326
Labeler code: 70700
Product ID: 70700-326_6e7f2a2a-f320-8968-5591-feabd381aa54
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Norethindrone Acetate
Dosage form: TABLET
Route: ORAL
Labeler: Xiromed LLC
Application: ANDA205278
Marketing category: ANDA
Marketing start: 2024-09-06
Substance: NORETHINDRONE ACETATE
Active strength: 5 mg/1
Pharmacologic classes: Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A205278-001	NORETHINDRONE ACETATE	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB		2016-11-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205278-001	AB

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 · 44 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	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205278-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2016-11-10	`3a93d1ddd44b…`

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	A205278-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A205278-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205278-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205278-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205278-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205278-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205278-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205278-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205278-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205278-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205278-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205278-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205278-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205278-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205278-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205278-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205278-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205278-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205278-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205278-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205278-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205278-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205278-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205278-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205278-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205278-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205278-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205278-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205278-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205278-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205278-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205278-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205278-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205278-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205278-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205278-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205278-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205278-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205278-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205278-001	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Gallifrey
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NORETHINDRONE ACETATE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9S44LIC7OJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1000405	Internal RxNorm lookup
2696255	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
26130af6-221b-2349-81b6-0c0132d6e524	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d39a542a-f5b0-4c2d-a820-0f5d39e6621f	Product name	1	20250307
859c4b0b-8cba-4f41-9afe-cc181a01fb62	Product name	2	20240215
0d9f32e2-f85b-4d63-9f04-b06059c34749	Product name	3	20230323
833edb59-a012-45c2-aff5-2ed74b66fa59	Product name	1	20201207
cec4644c-0fed-4608-a5ea-d3a1b1b6d697	Product name	2	20200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424	Product name	6	20200716
f4d31098-441e-52d3-27f1-49c829f8a3a1	Product name	5	20190703
c21bcd2e-ecbd-48e6-ab68-12cc12256c0f	Product name	2	20190213
c6636356-4ccb-40e9-a952-59eb1f2fc859	Product name	4	20180806
e042bc86-5d40-8945-82f8-de9dd95420dd	Product name	6	20180606
390e6d23-3a11-4327-9294-c958a378baae	Product name	4	20180124
b651f154-0364-4007-9dc6-9d33036db1d7	Product name	4	20170808
3395ac9b-f30b-4991-80ba-fd5196be0214	Product name	3	20170802
a5e2d962-d98c-4fbf-8183-ffd42dd01e19	Product name	6	20170711
00606b81-6e33-4c38-9ca9-bd14bd74d84c	Product name	4	20170501
f4ce24e8-8632-4fad-9984-b693f985f80f	Product name	3	20170501
b17c5419-b38b-579f-10bc-8a4ce69fc044	Product name	5	20170316
f6ac5560-6d3b-d281-41d2-adc50d283c20	Product name	3	20170228
01996782-abcb-4e6d-bcaf-4a23e6a95c0c	Product name	1	20160714
2aecf0b6-88a0-49e5-92e1-983c700c116c	Product name	1	20151222
61972742-5d4d-491d-a881-b6bc3a011577	Product name	1	20151113
23ede539-308f-46e5-817b-41ef23af8d40	Product name	1	20150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4d	Product name	1	20150930
5e13e814-349e-3480-99f3-ee22a591426f	Product name	2	20150518
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70700-326-50	Gallifrey	50 in 1 BOTTLE	TABLET	50		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70700-326-50	EA - Each	70700-326	61b2230b-d5d0-4b62-904e-0324b3e92095	1	2024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70700-326	GALLIFREY (NORETHINDRONE ACETATE) TABLET [XIROMED LLC]	1	Current NDC, 1 package rows	20241101_26130af6-221b-2349-81b6-0c0132d6e524.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9S44LIC7OJ	NORETHINDRONE ACETATE	51-98-9	NORETHINDRONE ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2696255	Gallifrey 5 MG Oral Tablet	PSN	26130af6-221b-2349-81b6-0c0132d6e524	2
1000405	norethindrone acetate 5 MG Oral Tablet	PSN	26130af6-221b-2349-81b6-0c0132d6e524	2
2696255	norethindrone acetate 5 MG Oral Tablet [Gallifrey]	SBD	26130af6-221b-2349-81b6-0c0132d6e524	2
1000405	norethindrone acetate 5 MG Oral Tablet	SCD	26130af6-221b-2349-81b6-0c0132d6e524	2
2696255	Gallifrey 5 MG Oral Tablet	SY	26130af6-221b-2349-81b6-0c0132d6e524	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70700-326-50	70700032650	50 TABLET in 1 BOTTLE (70700-326-50)	50 tablet	2024-09-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gallifrey ® (Norethindrone Acetate Tablets USP, 5 mg) Rx Only	Xiromed LLC \| Xiromed, LLC	2026-06-27	HUMAN PRESCRIPTION DRUG LABEL	3