Clindamycin Hydrochloride

Product NDC: 43063-394
11-digit product format: 430630394
Labeler code: 43063
Product ID: 43063-394_e688142c-26bb-91f5-e053-2995a90ab825
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clindamycin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA065243
Marketing category: ANDA
Marketing start: 2012-01-06
Marketing end: 0000-00-00
Substance: CLINDAMYCIN HYDROCHLORIDE
Active strength: 150 mg/1
Pharmacologic classes: Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 15 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43063-394		D	Discontinued by firm	2026-08-03
excluded package	package	43063-394	43063-394-04	D	Discontinued by firm	2026-08-03
excluded package	package	43063-394	43063-394-06	D	Discontinued by firm	2026-08-03
excluded package	package	43063-394	43063-394-08	D	Discontinued by firm	2026-08-03
excluded package	package	43063-394	43063-394-15	D	Discontinued by firm	2026-08-03
excluded package	package	43063-394	43063-394-17	D	Discontinued by firm	2026-08-03
excluded package	package	43063-394	43063-394-20	D	Discontinued by firm	2026-08-03
excluded package	package	43063-394	43063-394-21	D	Discontinued by firm	2026-08-03
excluded package	package	43063-394	43063-394-28	D	Discontinued by firm	2026-08-03
excluded package	package	43063-394	43063-394-30	D	Discontinued by firm	2026-08-03
excluded package	package	43063-394	43063-394-40	D	Discontinued by firm	2026-08-03
excluded package	package	43063-394	43063-394-42	D	Discontinued by firm	2026-08-03
excluded package	package	43063-394	43063-394-56	D	Discontinued by firm	2026-08-03
excluded package	package	43063-394	43063-394-60	D	Discontinued by firm	2026-08-03
excluded package	package	43063-394	43063-394-80	D	Discontinued by firm	2026-08-03

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 3 · 180 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	43063-394-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-394-56	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-394-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-394-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-394-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-394-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-394-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-394-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-394-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-394-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-394-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-394-17	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-394-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-394-40	`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	43063-394-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-394-56	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-394-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-394-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-394-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-394-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-394-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-394-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-394-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-394-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-394-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-394-17	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-394-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-394-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-394-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-394-56	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-394-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-394-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-394-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-394-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-394-42	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-394-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-394-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-394-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-394-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-394-17	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-394-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-394-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-394-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-394-56	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-394-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-394-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-394-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-394-80	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-394-42	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-394-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-394-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-394-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-394-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-394-17	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-394-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-394-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A065243-001	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12
A065243-002	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12
A065243-003	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065243-002	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 4 · 123 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	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 53 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	A065243-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065243-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065243-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065243-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065243-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065243-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065243-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065243-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065243-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065243-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065243-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065243-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065243-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065243-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065243-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065243-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065243-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065243-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065243-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065243-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065243-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065243-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065243-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065243-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065243-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065243-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065243-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065243-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065243-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065243-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065243-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065243-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065243-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065243-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065243-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065243-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065243-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065243-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065243-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065243-002	AB	1	`6a51e52b5d6a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-394-04	EA - Each	43063-394	6a259198-102f-4c92-a55f-c793b09c1212	1	2013-02-13
43063-394-06	EA - Each	43063-394	82e047f9-b552-4f54-abd5-f31582edf41a	1	2013-02-13
43063-394-08	EA - Each	43063-394	c41a4790-a1f9-492d-8131-aa372b736fb2	1	2020-05-08
43063-394-15	EA - Each	43063-394	94796596-8985-4ee9-be6e-9bfb80061ec0	1	2013-02-13
43063-394-17	EA - Each	43063-394	d2fe90d1-d528-42fa-8642-e734ea6e21d9	1	2013-02-13
43063-394-20	EA - Each	43063-394	5df0b8da-d68d-4f39-8270-23d5a3d07462	1	2013-02-13
43063-394-21	EA - Each	43063-394	6a19e92e-8139-40ea-9f9c-61970d12b9b0	1	2019-11-12
43063-394-28	EA - Each	43063-394	a6e9d433-0187-4e36-8b61-45d6733d3f1d	1	2013-02-13
43063-394-30	EA - Each	43063-394	64e6123f-ee78-4e46-9042-930c4a38186c	1	2013-02-13
43063-394-40	EA - Each	43063-394	f5d1922e-eb61-49ea-9c18-fe4ceea5a08c	1	2013-02-13
43063-394-42	EA - Each	43063-394	c5a8366c-8531-430d-9726-2c1b086a5fba	1	2013-02-13
43063-394-56	EA - Each	43063-394	2c434e04-9c3d-4096-a4d7-d8f023013181	1	2013-02-13
43063-394-60	EA - Each	43063-394	c95cdc85-d22f-4299-af53-b60c8b18a9af	1	2013-02-13
43063-394-80	EA - Each	43063-394	04dcaa56-ccaf-45ac-9afd-959b1c0102c8	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLINDAMYCIN HYDROCHLORIDE	ACTIVE INGREDIENT	T20OQ1YN1W	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	14
CLINDAMYCIN	ACTIVE MOIETY	3U02EL437C	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	14
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	14
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	14
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	14
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	14
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	14
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	14
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	14
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	14
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	14
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	14
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	14
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	14
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	14
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	14
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	14
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	14
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	14

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
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Chartwell RX, LLC	e8167412-882e-4143-93c6-49e68adbcf16	2024-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065243 application number: ANDA065243

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
T20OQ1YN1W	CLINDAMYCIN HYDROCHLORIDE	21462-39-5	CLINDAMYCIN HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-394-04	43063039404	4 CAPSULE in 1 BOTTLE, PLASTIC (43063-394-04)	4 capsule	2012-01-06	0000-00-00	No	No	Current
43063-394-06	43063039406	6 CAPSULE in 1 BOTTLE, PLASTIC (43063-394-06)	6 capsule	2012-01-06	0000-00-00	No	No	Current
43063-394-08	43063039408	8 CAPSULE in 1 BOTTLE, PLASTIC (43063-394-08)	8 capsule	2012-01-06	0000-00-00	No	No	Current
43063-394-15	43063039415	15 CAPSULE in 1 BOTTLE, PLASTIC (43063-394-15)	15 capsule	2012-01-06	0000-00-00	No	No	Current
43063-394-17	43063039417	17 CAPSULE in 1 BOTTLE, PLASTIC (43063-394-17)	17 capsule	2012-01-06	0000-00-00	No	No	Current
43063-394-20	43063039420	20 CAPSULE in 1 BOTTLE, PLASTIC (43063-394-20)	20 capsule	2012-01-06	0000-00-00	No	No	Current
43063-394-21	43063039421	21 CAPSULE in 1 BOTTLE, PLASTIC (43063-394-21)	21 capsule	2012-01-06	0000-00-00	No	No	Current
43063-394-28	43063039428	28 CAPSULE in 1 BOTTLE, PLASTIC (43063-394-28)	28 capsule	2012-01-06	0000-00-00	No	No	Current
43063-394-30	43063039430	30 CAPSULE in 1 BOTTLE, PLASTIC (43063-394-30)	30 capsule	2012-01-06	0000-00-00	No	No	Current
43063-394-40	43063039440	40 CAPSULE in 1 BOTTLE, PLASTIC (43063-394-40)	40 capsule	2012-01-06	0000-00-00	No	No	Current
43063-394-42	43063039442	42 CAPSULE in 1 BOTTLE, PLASTIC (43063-394-42)	42 capsule	2012-01-06	0000-00-00	No	No	Current
43063-394-56	43063039456	56 CAPSULE in 1 BOTTLE, PLASTIC (43063-394-56)	56 capsule	2012-01-06	0000-00-00	No	No	Current
43063-394-60	43063039460	60 CAPSULE in 1 BOTTLE, PLASTIC (43063-394-60)	60 capsule	2012-01-06	0000-00-00	No	No	Current
43063-394-80	43063039480	80 CAPSULE in 1 BOTTLE, PLASTIC (43063-394-80)	80 capsule	2012-01-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clindamycin Hydrochloride Capsules, USP	PD-Rx Pharmaceuticals, Inc.	2022-08-18	HUMAN PRESCRIPTION DRUG LABEL	45