Doxycycline

Product NDC: 0115-1327
Requested package NDC: 0115-1327-03
11-digit product format: 001151327
Labeler code: 0115
Product ID: 0115-1327_25e3946b-93e0-40f2-9ca6-d96b9b1c1476
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline
Dosage form: CAPSULE
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA200065
Marketing category: ANDA
Marketing start: 2011-02-17
Marketing end: 0000-00-00
Substance: DOXYCYCLINE
Active strength: 150 mg/1
Pharmacologic classes: Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0115-1327	0115-1327-03	I	Inactivated by FDA		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A200065-001	DOXYCYCLINE	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL			2011-02-17

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	2011-02-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	2011-02-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	2011-02-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	2011-02-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	2011-02-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	2011-02-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	2011-02-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	2011-02-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	2011-02-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	2011-02-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	2011-02-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	A200065-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200065-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200065-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200065-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200065-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200065-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200065-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200065-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200065-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200065-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200065-001	AB	1	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b4321c75-2e87-4d90-9726-9a28fb2293a3	Product name	3	20260112
5e99724e-0654-4aec-b7a2-0b9b10e312ee	Product name	3	20250227
d2d36660-68ce-7e7d-0630-ec4b0d859fad	Product name	6	20220921
a239f4dd-cf93-4660-b190-f97d000f249f	Product name	7	20210607
a9d03566-caeb-4466-8021-74599b048880	Product name	3	20210604
12750814-20f7-4f35-b5fa-dbc8811ba858	Product name	9	20201007
00a5dbaa-1b7d-4e56-be0c-fedc7bbf5ade	Product name	1	20200706
7b4b06ac-8c50-45f0-9556-293ea558a294	Product name	1	20180808
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84	Product name	5	20171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371	Product name	2	20171115
58b1278c-6dce-49b6-a05e-ea16f389acba	Product name	1	20160620

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0115-1327-01	2023-01-30	C162847	48780-1	f386c649-e6b7-0266-e053-dadaa90a7c1a	Doxycycline Capsules, USP
0115-1327-03	2023-01-30	C162847	48780-1	f386c649-e6b7-0266-e053-dadaa90a7c1a	Doxycycline Capsules, USP
0115-1327-08	2023-01-30	C162847	48780-1	f386c649-e6b7-0266-e053-dadaa90a7c1a	Doxycycline Capsules, USP
0115-1327-10	2023-01-30	C162847	48780-1	f386c649-e6b7-0266-e053-dadaa90a7c1a	Doxycycline Capsules, USP
0115-1327-13	2023-01-30	C162847	48780-1	f386c649-e6b7-0266-e053-dadaa90a7c1a	Doxycycline Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0115-1327-01	Doxycycline	100 in 1 BOTTLE	CAPSULE	100	13
0115-1327-03	Doxycycline	1000 in 1 BOTTLE	CAPSULE	1000	13
0115-1327-08	Doxycycline	30 in 1 BOTTLE	CAPSULE	30	13
0115-1327-10	Doxycycline	90 in 1 BOTTLE	CAPSULE	90	13
0115-1327-13	Doxycycline	60 in 1 BOTTLE	CAPSULE	60	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0115-1327-13	EA - Each	0115-1327	2a5ed75f-91b8-43ad-8ba0-22439cdbc7d7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOXYCYCLINE	ACTIVE INGREDIENT	N12000U13O	DOXYCYCLINE CAPSULE [IMPAX GENERICS]	7
DOXYCYCLINE ANHYDROUS	ACTIVE MOIETY	334895S862	DOXYCYCLINE CAPSULE [IMPAX GENERICS]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DOXYCYCLINE CAPSULE [IMPAX GENERICS]	7
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DOXYCYCLINE CAPSULE [IMPAX GENERICS]	7
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DOXYCYCLINE CAPSULE [IMPAX GENERICS]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DOXYCYCLINE CAPSULE [IMPAX GENERICS]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DOXYCYCLINE CAPSULE [IMPAX GENERICS]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DOXYCYCLINE CAPSULE [IMPAX GENERICS]	7
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	DOXYCYCLINE CAPSULE [IMPAX GENERICS]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DOXYCYCLINE CAPSULE [IMPAX GENERICS]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0115-1327	DOXYCYCLINE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	13	Legacy NDC, 5 package rows	20200131_5878bfaf-66b2-4a78-b6b0-f6405d44ebef.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N12000U13O	DOXYCYCLINE	17086-28-1	DOXYCYCLINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
728207	doxycycline monohydrate 150 MG Oral Capsule	PSN	5878bfaf-66b2-4a78-b6b0-f6405d44ebef	13
728207	doxycycline monohydrate 150 MG Oral Capsule	SCD	5878bfaf-66b2-4a78-b6b0-f6405d44ebef	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0115-1327-03	00115132703	1000 CAPSULE in 1 BOTTLE (0115-1327-03)	1000 capsule	2011-02-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxycycline Capsules, USP	Amneal Pharmaceuticals of New York LLC \| BORA PHARMACEUTICAL LABORATORIES INC.	2020-01-24	HUMAN PRESCRIPTION DRUG LABEL	13