Doxycycline Hyclate

Product NDC: 12634-169
11-digit product format: 126340169
Labeler code: 12634
Product ID: 12634-169_46dff4c0-9aad-20f9-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DOXYCYCLINE HYCLATE
Dosage form: CAPSULE
Route: ORAL
Labeler: Apotheca Inc.
Application: ANDA062500
Marketing category: ANDA
Marketing start: 1984-09-11
Marketing end: 0000-00-00
Substance: DOXYCYCLINE HYCLATE
Active strength: 100 mg/1
Pharmacologic classes: Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 39 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	12634-169		I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-00	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-01	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-09	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-12	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-18	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-40	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-42	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-45	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-50	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-52	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-54	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-57	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-59	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-60	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-61	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-63	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-66	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-67	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-69	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-71	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-74	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-78	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-79	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-80	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-81	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-82	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-84	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-85	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-90	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-91	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-92	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-93	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-94	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-95	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-96	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-97	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-98	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-169	12634-169-99	I	Inactivated by FDA	2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 14 · 819 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-79	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-67	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-98	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-81	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-66	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-99	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-97	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-95	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-84	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-54	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-93	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-94	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-74	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-82	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-52	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-69	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-92	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-169-63	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-169-59	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-169-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-169-79	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-169-67	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-169-98	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-169-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-169-81	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-169-66	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-169-99	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-169-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-169-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-169-97	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-169-95	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-169-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-169-84	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-169-54	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-169-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-169-93	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-169-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-169-94	`f5e01cc5f278…`	`a2eaf40c39c3…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062500-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-09-11
A062500-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-09-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A062500-001	AB
A062500-002	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 3 · 82 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	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062500-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062500-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062500-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062500-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062500-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062500-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062500-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062500-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062500-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062500-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062500-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062500-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062500-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062500-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062500-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062500-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062500-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062500-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062500-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062500-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062500-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062500-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062500-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062500-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062500-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062500-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062500-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062500-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062500-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062500-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062500-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062500-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062500-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062500-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062500-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062500-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062500-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062500-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062500-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062500-002	AB	1	`782e0a99824c…`

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, Related label table
NDC	Related label
12634-169-00	Doxycycline Hyclate Capsules, USP
12634-169-01	Doxycycline Hyclate Capsules, USP
12634-169-09	Doxycycline Hyclate Capsules, USP
12634-169-12	Doxycycline Hyclate Capsules, USP
12634-169-18	Doxycycline Hyclate Capsules, USP
12634-169-40	Doxycycline Hyclate Capsules, USP
12634-169-42	Doxycycline Hyclate Capsules, USP
12634-169-45	Doxycycline Hyclate Capsules, USP
12634-169-50	Doxycycline Hyclate Capsules, USP
12634-169-52	Doxycycline Hyclate Capsules, USP
12634-169-54	Doxycycline Hyclate Capsules, USP
12634-169-57	Doxycycline Hyclate Capsules, USP
12634-169-59	Doxycycline Hyclate Capsules, USP
12634-169-60	Doxycycline Hyclate Capsules, USP
12634-169-61	Doxycycline Hyclate Capsules, USP
12634-169-63	Doxycycline Hyclate Capsules, USP
12634-169-66	Doxycycline Hyclate Capsules, USP
12634-169-67	Doxycycline Hyclate Capsules, USP
12634-169-69	Doxycycline Hyclate Capsules, USP
12634-169-71	Doxycycline Hyclate Capsules, USP
12634-169-74	Doxycycline Hyclate Capsules, USP
12634-169-78	Doxycycline Hyclate Capsules, USP
12634-169-79	Doxycycline Hyclate Capsules, USP
12634-169-80	Doxycycline Hyclate Capsules, USP
12634-169-81	Doxycycline Hyclate Capsules, USP
12634-169-82	Doxycycline Hyclate Capsules, USP
12634-169-84	Doxycycline Hyclate Capsules, USP
12634-169-85	Doxycycline Hyclate Capsules, USP
12634-169-90	Doxycycline Hyclate Capsules, USP
12634-169-91	Doxycycline Hyclate Capsules, USP
12634-169-92	Doxycycline Hyclate Capsules, USP
12634-169-93	Doxycycline Hyclate Capsules, USP
12634-169-94	Doxycycline Hyclate Capsules, USP
12634-169-95	Doxycycline Hyclate Capsules, USP
12634-169-96	Doxycycline Hyclate Capsules, USP
12634-169-97	Doxycycline Hyclate Capsules, USP
12634-169-98	Doxycycline Hyclate Capsules, USP
12634-169-99	Doxycycline Hyclate Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-169-00	Doxycycline Hyclate	10 in 1 BOTTLE	CAPSULE	10	1
12634-169-01	Doxycycline Hyclate	100 in 1 BOTTLE	CAPSULE	100	1
12634-169-09	Doxycycline Hyclate	35 in 1 BOTTLE	CAPSULE	35	1
12634-169-12	Doxycycline Hyclate	120 in 1 BOTTLE	CAPSULE	120	1
12634-169-18	Doxycycline Hyclate	180 in 1 BOTTLE	CAPSULE	180	1
12634-169-40	Doxycycline Hyclate	40 in 1 BOTTLE	CAPSULE	40	1
12634-169-42	Doxycycline Hyclate	42 in 1 BOTTLE	CAPSULE	42	1
12634-169-45	Doxycycline Hyclate	45 in 1 BOTTLE	CAPSULE	45	1
12634-169-50	Doxycycline Hyclate	50 in 1 BOTTLE	CAPSULE	50	1
12634-169-52	Doxycycline Hyclate	12 in 1 BLISTER PACK	CAPSULE	12	1
12634-169-54	Doxycycline Hyclate	14 in 1 BLISTER PACK	CAPSULE	14	1
12634-169-57	Doxycycline Hyclate	20 in 1 BLISTER PACK	CAPSULE	20	1
12634-169-59	Doxycycline Hyclate	30 in 1 BLISTER PACK	CAPSULE	30	1
12634-169-60	Doxycycline Hyclate	60 in 1 BOTTLE	CAPSULE	60	1
12634-169-61	Doxycycline Hyclate	10 in 1 BLISTER PACK	CAPSULE	10	1
12634-169-63	Doxycycline Hyclate	3 in 1 BLISTER PACK	CAPSULE	3	1
12634-169-66	Doxycycline Hyclate	6 in 1 BLISTER PACK	CAPSULE	6	1
12634-169-67	Doxycycline Hyclate	7 in 1 BLISTER PACK	CAPSULE	7	1
12634-169-69	Doxycycline Hyclate	9 in 1 BLISTER PACK	CAPSULE	9	1
12634-169-71	Doxycycline Hyclate	30 in 1 BOTTLE	CAPSULE	30	1
12634-169-74	Doxycycline Hyclate	24 in 1 BOTTLE	CAPSULE	24	1
12634-169-78	Doxycycline Hyclate	28 in 1 BOTTLE	CAPSULE	28	1
12634-169-79	Doxycycline Hyclate	25 in 1 BOTTLE	CAPSULE	25	1
12634-169-80	Doxycycline Hyclate	20 in 1 BOTTLE	CAPSULE	20	1
12634-169-81	Doxycycline Hyclate	21 in 1 BOTTLE	CAPSULE	21	1
12634-169-82	Doxycycline Hyclate	12 in 1 BOTTLE	CAPSULE	12	1
12634-169-84	Doxycycline Hyclate	14 in 1 BOTTLE	CAPSULE	14	1
12634-169-85	Doxycycline Hyclate	15 in 1 BOTTLE	CAPSULE	15	1
12634-169-90	Doxycycline Hyclate	90 in 1 BOTTLE	CAPSULE	90	1
12634-169-91	Doxycycline Hyclate	1 in 1 BLISTER PACK	CAPSULE	1	1
12634-169-92	Doxycycline Hyclate	2 in 1 BOTTLE	CAPSULE	2	1
12634-169-93	Doxycycline Hyclate	3 in 1 BOTTLE	CAPSULE	3	1
12634-169-94	Doxycycline Hyclate	4 in 1 BOTTLE	CAPSULE	4	1
12634-169-95	Doxycycline Hyclate	5 in 1 BOTTLE	CAPSULE	5	1
12634-169-96	Doxycycline Hyclate	6 in 1 BOTTLE	CAPSULE	6	1
12634-169-97	Doxycycline Hyclate	7 in 1 BOTTLE	CAPSULE	7	1
12634-169-98	Doxycycline Hyclate	8 in 1 BOTTLE	CAPSULE	8	1
12634-169-99	Doxycycline Hyclate	9 in 1 BOTTLE	CAPSULE	9	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-169	DOXYCYCLINE HYCLATE CAPSULE [APOTHECA INC.]	1	Legacy NDC, 38 package rows	20170125_46dff4c0-9aac-20f9-e054-00144ff8d46c.zip

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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
doxycycline hyclate	DOXYCYCLINE HYCLATE	HAWAII REPACK, INC	88c429a1-351d-432e-b69b-d7a0afca482a	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
doxycycline hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	0aaa4ff7-7fba-4a40-9b49-82e4da68a48f	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
doxycycline hyclate	DOXYCYCLINE HYCLATE	Sportpharm LLC	50617adc-8528-414d-bb6c-78887d404983	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
doxycycline hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	6e06e73c-b777-4a2d-988f-b009f2fc34d1	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
doxycycline hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	6f530f28-8c10-41dc-818f-1aef2306bde5	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Health Department, Oklahoma State	f39365f9-eb64-00cb-e053-2995a90a8d80	2025-12-31	Warnings	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
doxycycline hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	6624a43a-28ff-4d55-b5dd-1e805bfa8778	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
doxycycline	DOXYCYCLINE	Chartwell Governmental & Specialty RX, LLC	b8486639-7eb9-4610-9cd4-0e922045d592	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
doxycycline	DOXYCYCLINE	Chartwell RX LLC	3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Asclemed USA, Inc.	a5571acf-3284-4559-8cc0-b4856ac6d94d	2025-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	a5f02688-cbba-4d9b-e053-2995a90ad1ba	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	a2161675-505c-3d65-e053-2995a90aa644	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
doxycycline hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	a2df1a8c-7a22-462d-830a-04e6ac5a912f	2024-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
doxycycline hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	1dd7a94e-bf29-4f07-9476-ac8d1f9ab565	2024-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
doxycycline hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	4164f6b7-5ebd-4f5f-a536-9a37b2e0562c	2024-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
doxycycline hyclate	DOXYCYCLINE HYCLATE	Proficient Rx LP	2993ac3d-0ec4-4230-858e-9fd00063cf57	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
doxycycline hyclate	DOXYCYCLINE HYCLATE	Proficient Rx LP	3303b423-b270-495b-9360-e43144fcf6f2	2021-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
19XTS3T51U	DOXYCYCLINE HYCLATE	24390-14-5	DOXYCYCLINE HYCLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	46dff4c0-9aac-20f9-e054-00144ff8d46c	1
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	46dff4c0-9aac-20f9-e054-00144ff8d46c	1
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	46dff4c0-9aac-20f9-e054-00144ff8d46c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
12634-169-00	12634016900	10 in 1 BOTTLE	Historical
12634-169-01	12634016901	100 in 1 BOTTLE	Historical
12634-169-09	12634016909	35 in 1 BOTTLE	Historical
12634-169-12	12634016912	120 in 1 BOTTLE	Historical
12634-169-18	12634016918	180 in 1 BOTTLE	Historical
12634-169-40	12634016940	40 in 1 BOTTLE	Historical
12634-169-42	12634016942	42 in 1 BOTTLE	Historical
12634-169-45	12634016945	45 in 1 BOTTLE	Historical
12634-169-50	12634016950	50 in 1 BOTTLE	Historical
12634-169-52	12634016952	12 in 1 BLISTER PACK	Historical
12634-169-54	12634016954	14 in 1 BLISTER PACK	Historical
12634-169-57	12634016957	20 in 1 BLISTER PACK	Historical
12634-169-59	12634016959	30 in 1 BLISTER PACK	Historical
12634-169-60	12634016960	60 in 1 BOTTLE	Historical
12634-169-61	12634016961	10 in 1 BLISTER PACK	Historical
12634-169-63	12634016963	3 in 1 BLISTER PACK	Historical
12634-169-66	12634016966	6 in 1 BLISTER PACK	Historical
12634-169-67	12634016967	7 in 1 BLISTER PACK	Historical
12634-169-69	12634016969	9 in 1 BLISTER PACK	Historical
12634-169-71	12634016971	30 in 1 BOTTLE	Historical
12634-169-74	12634016974	24 in 1 BOTTLE	Historical
12634-169-78	12634016978	28 in 1 BOTTLE	Historical
12634-169-79	12634016979	25 in 1 BOTTLE	Historical
12634-169-80	12634016980	20 in 1 BOTTLE	Historical
12634-169-81	12634016981	21 in 1 BOTTLE	Historical
12634-169-82	12634016982	12 in 1 BOTTLE	Historical
12634-169-84	12634016984	14 in 1 BOTTLE	Historical
12634-169-85	12634016985	15 in 1 BOTTLE	Historical
12634-169-90	12634016990	90 in 1 BOTTLE	Historical
12634-169-91	12634016991	1 in 1 BLISTER PACK	Historical
12634-169-92	12634016992	2 in 1 BOTTLE	Historical
12634-169-93	12634016993	3 in 1 BOTTLE	Historical
12634-169-94	12634016994	4 in 1 BOTTLE	Historical
12634-169-95	12634016995	5 in 1 BOTTLE	Historical
12634-169-96	12634016996	6 in 1 BOTTLE	Historical
12634-169-97	12634016997	7 in 1 BOTTLE	Historical
12634-169-98	12634016998	8 in 1 BOTTLE	Historical
12634-169-99	12634016999	9 in 1 BOTTLE	Historical